Bone graft delivery system and method for using same

ABSTRACT

A bone graft delivery system and method for using same to deliver graft material into a surgical site. The method includes the steps of providing a hollow tube configured to receive the graft material, releasably attaching an implant to a distal end of the hollow tube so as to communicate with at least one opening in the distal end of the hollow tube, the implant being configured to receive the graft material delivered through the hollow tube; placing the implant within the surgical site; advancing the graft material through the hollow tube; conveying graft material through the hollow tube into an interior of the implant, whereby the implant is at least substantially filled with the graft material; and discharging the graft material through at least one opening in the implant into the surgical site, whereby the surgical site is at least substantially filled with the graft material.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/373,410, filed Apr. 2, 2019, which is a continuation-in-part of U.S.patent application Ser. No. 16/198,754, filed Nov. 21, 2018 (now U.S.Pat. No. 10,245,159, issued Apr. 2, 2019), which is acontinuation-in-part of U.S. patent application Ser. No. 15/486,511,filed Apr. 13, 2017 (now U.S. Pat. No. 10,195,053, issued Feb. 5, 2019),which is a continuation of U.S. patent application Ser. No. 14/887,598,filed Oct. 20, 2015 (now U.S. Pat. No. 9,629,729, issued Apr. 25, 2017),which is a continuation-in-part of U.S. patent application Ser. No.14/263,963, filed Apr. 28, 2014 (now U.S. Pat. No. 9,186,193, issuedNov. 17, 2015), which is a continuation-in-part of U.S. patentapplication Ser. No. 14/088,148, filed Nov. 22, 2013 (now U.S. Pat. No.8,709,088, issued Apr. 29, 2014), which is a continuation of U.S. patentapplication Ser. No. 13/947,255, filed Jul. 22, 2013 (now U.S. Pat. No.8,685,031, issued Apr. 1, 2014), which is a continuation-in-part of U.S.patent application Ser. No. 13/714,971, filed Dec. 14, 2012 (now U.S.Pat. No. 9,173,694, issued Nov. 3, 2015), which is acontinuation-in-part of U.S. patent application Ser. No. 13/367,295,filed Feb. 6, 2012 (now U.S. Pat. No. 9,060,877, issued Jun. 23, 2015),which is a continuation-in-part of U.S. patent application Ser. No.12/886,452, filed Sep. 20, 2010 (now U.S. Pat. No. 8,906,028, issuedDec. 9, 2014), which claims the benefit of U.S. Provisional ApplicationNo. 61/243,664, filed on Sep. 18, 2009. This application also claims thebenefit of U.S. Provisional Application No. 62/696,093, filed on Jul.10, 2018. The disclosures of each of the above-referenced applicationsis incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

This disclosure relates to orthopedic surgery, and more specifically toan apparatus and method for integrated delivery of bone graft materialduring the placement of surgical cages or other medical implants in apatient's spine.

BACKGROUND OF THE INVENTION

According to the American Academy of Orthopedic Surgeons, about 250,000spinal fusion surgeries are performed every year, mostly on adultsbetween the ages of 45 to 64. Spinal fusion is a process by which two ormore of the vertebrae that make up the spinal column are fused togetherwith bone grafts and internal devices (such as rods) that heal into asingle solid bone. Spinal fusion can eliminate unnatural motion betweenthe vertebrae and, in turn, reduce pressure on nerve endings. Inaddition, spinal fusion can be used to treat, for example, injuries tospinal vertebrae caused by trauma; protrusion and degeneration of thecushioning disc between vertebrae (sometimes called slipped disc orherniated disc); abnormal curvatures (such as scoliosis or kyphosis);and weak or unstable spine caused by infections or tumors.

Individuals who suffer degenerative disc disease, natural spinedeformations, a herniated disc, spine injuries or other spine disordersmay require surgery on the affected region to relieve the individualfrom pain and prevent further injury to the spine and nerves. Spinalsurgery may involve removal of damaged joint tissue, insertion of atissue implant and/or fixation of two or more adjacent vertebral bodies.In some instances a medical implant is also inserted, such as a fusioncage. The surgical procedure will vary depending on the nature andextent of the injury. Generally, there are five main types of lumbarfusion, including: posterior lumbar fusion (“PLF”), posterior lumbarinterbody fusion (“PLIF”), anterior lumbar interbody fusion (“ALIF”),circumferential 360 fusion, and transforaminal lumbar interbody fusion(“TLIF”). More recently, direct lateral interbody fusion (“D-LIF”) hasbecome available. A posterior approach is one that accesses the surgicalsite from the patient's back, an anterior approach is one that accessesthe surgical site from the patient's front or chest, and a directlateral approach is one that accesses the surgical site from thepatient's side. There are similar approaches for fusion in the interbodyor cervical spine regions. For a general background on some of theseprocedures and the tools and apparatus used in certain procedures, seeU.S. Prov. Pat. Appl. No. 61/120,260 filed on Dec. 5, 2008, the entiredisclosure of which is incorporated by reference in its entirety. Inaddition, further background on procedures and tools and apparatus usedin spinal procedures is found in U.S. patent application Ser. No.12/632,720 filed on Dec. 7, 2009, now U.S. Pat. No. 8,366,748, theentire disclosure of which is incorporated by reference in its entirety.

Vertebrectomy, or the removal or excision of a vertebra, is another typeof spinal surgery that may be necessary to alleviate pain and/or correctspinal defects, such as when disk material above and below a particularvertebra protrudes from the spine and contacts the spinal cord. Once theproblematic vertebra is removed, a specialized fusion cage (also calleda vertebrectomy cage) may be inserted into its place to restorestructural continuity to the spine.

Some disadvantages of traditional methods of spinal surgery include, forexample, the pain associated with the procedure, the length of theprocedure, the complexity of implements used to carry out the procedure,the prolonged hospitalization required to manage pain, the risk ofinfection due to the invasive nature of the procedure, and the possiblerequirement of a second procedure to harvest autograft bone from theiliac crest or other suitable site on the patient for generating therequired quantity of cancellous and/or cortical bone.

A variety of semisolid bone graft materials are available on the marketwhich ostensibly increase spinal fusion rates without the morbidity ofautograft bone harvest. Each of the manufacturers espouses their productas the most advantageous for healing. These products all have similarhandling characteristics and the literature reveals that they havesimilar healing prospects. They come in a syringe and it is up to thesurgeon to apply the selected material to the target site. The mostcommon site for application is to the disk space after it has beenprepared to a bleeding bed and ready to accept a cage and/or thegrafting material. This represents a long and narrow channel even inopen procedures. The surgeon is left to his own devices as to how to getthe graft from its container to the active site. The devices which havebeen used have included a “caulking gun” construct and a variety ofbarrel shaft with a plunger design.

Bone graft typically includes crushed bone (cancellous and cortical), ora combination of these (and/or other natural materials), and may furthercomprise synthetic biocompatible materials. Bone graft of this type isintended to stimulate growth of healthy bone. As used herein, “bonegraft” shall mean materials made up entirely of natural materials,entirely of synthetic biocompatible materials, or any combination ofthese materials. Bone graft often is provided by the supplier in a gelor slurry form, as opposed to a dry or granule form. Many companiesprovide various forms of bone graft in varying degrees of liquidity andviscosity, which may cause problems in certain prior art deliverydevices in both prepackaged or packaged by the surgeon embodiments. Inaddition, the method of delivery of bone graft to a particular locationvaries depending on the form of the bone graft utilized.

Autogenous bone (bone from the patient) or allograft bone (bone fromanother individual) are the most commonly used materials to induce boneformation. Generally, small pieces of bone are placed into the spacebetween the vertebrae to be fused. Sometimes larger solid pieces of boneare used to provide immediate structural support. Autogenous bone isgenerally considered superior at promoting fusion. However, thisprocedure requires extra surgery to remove bone from another area of thepatient's body such as the pelvis or fibula. Thus, it has been reportedthat about 30 percent of patients have significant pain and tendernessat the graft harvest site, which may be prolonged, and in some casesoutlast the back pain the procedure intended to correct. Similarly,allograft bone and other bone graft substitutes, although eliminatingthe need for a second surgery, have drawbacks in that they have yet tobe proven as cost effective and efficacious substitutes for autogenousbone fusion.

An alternative to autogenous or allograft bone is the use of growthfactors that promote bone formation. For example, studies have shownthat the use of bone morphogenic proteins (“BMPs”) results in betteroverall fusion, less time in the operating room and, more importantly,fewer complications for patients because it eliminates the need for thesecond surgery. However, use of BMPs, although efficacious in promotingbone growth, can be prohibitively expensive.

Another alternative is the use of a genetically engineered version of anaturally occurring bone growth factor. This approach also haslimitations. Specifically, surgeons have expressed concerns thatgenetically engineered BMPs can dramatically speed the growth ofcancerous cells or cause non-cancerous cells to become more sinister.Another concern is unwanted bone creation. There is a chance that bonegenerated by genetically engineered BMPs could form over the delicatenerve endings in the spine or, worse, somewhere else in the body.

Regenerative medicine, which harnesses the ability of regenerativecells, e.g., stem cells (i.e., the unspecialized master cells of thebody) to renew themselves indefinitely and develop into maturespecialized cells, may be a means of circumventing the limitations ofthe prior-art techniques. Stem cells, i.e., both embryonic and adultstem cells, have been shown to possess the nascent capacity to becomemany, if not all, of the 200+ cell and tissue types of the body,including bone. Recently, adipose tissue has been shown to be a sourceof adult stem cells (See e.g. Zuk, Patricia Z. et al., “MultilineageCells from Human Adipose Tissue: Implication for Cell-Based Therapies,”Tissue Engineering, April 2001, 7:211-28; Zuk, Patricia A. et al.,“Human Adipose Tissue Is A Source Of Multipotent Stem Cells,” MolecularBiology of the Cell, 2002, 13:4279-4295). Adipose tissue (unlike marrow,skin, muscle, liver and brain) is comparably easy to harvest inrelatively large amounts with low morbidity (See e.g. Commons, G. W.,Halperin, B., and Chang, C. C. (2001) “Large-volume liposuction: areview of 631 consecutive cases over 12 years” Plast. Reconstr. Surg.108, 1753-63; Katz, B. E., Bruck, M. C. and Coleman, W. P. 3 (2001b)“The benefits of powered liposuction versus traditional liposuction: apaired comparison analysis” Dermatol. Surg. 27, 863-7). Accordingly,given the limitations of the prior art spinal fusion techniques, thereexists a need for a device that incorporates regenerative cells, e.g.,stem cells that possess the ability to induce bone formation.

Many different methods and approaches have been attempted to induce boneformation or to promote spinal fusion. The traditional devices forinserting bone graft impair the surgeon's visualization of the operativesite, which can lead to imprecise insertion of bone graft and possibleharm to the patient. The caulking gun and the collection of largebarrel/plunger designs typically present components at the top of theirstructure which block the view of the surgical site. The surgeon mustthen resort to applying pressure to the surgical site to approximate thelocation of the device's delivery area. Such rough maneuvering canresult in imprecise placement of bone graft, and in some cases, ruptureof the surgical area by penetrating the annulus and entering theabdominal cavity. Also, in some surgical procedures, the devices forinserting bone graft material are applied within a cannula inserted orplaced in the surgical area, further limiting the size and/or profile ofthe bone graft insertion device. When a cannula is involved, sometraditional devices such as the large barrel/plunger designs and/or thechalking gun designs simply cannot be used as they cannot be insertedwithin the cannula.

Traditional devices for inserting bone graft deliver the bone graftmaterial at the bottom of the delivery device along the device'slongitudinal axis. Such a delivery method causes the bone graftingmaterial to become impacted at the bottom of the delivery device whichjams the device and promotes risk of rupture of the surgical area bypenetrating the annulus and entering the abdominal cavity. Further,traditional devices that deliver bone graft material along theirlongitudinal axis may cause rupture of the surgical area or harm to thepatient because of the ensuing pressure imparted by the ejected bonegraft material from the longitudinal axis of the device. Furthermore,the graft material is distributed only in the longitudinal axis and doesnot fill in the peripheral areas of the disk.

As mentioned, the method of delivery of bone graft to a particularlocation varies depending on the form of the bone graft utilized. Forexample, in the case of slurry type bone graft, various dispensingdevices have been developed having applicators designed to accommodatethis type of bone graft. One such device is disclosed by U.S. Pat. No.5,925,051 issued to Mikhail on Jul. 20, 1999 (“Mikhail”), the disclosureof which is incorporated herein by reference in its entirety. Mikhailprovides a caulking gun type dispenser for introducing bone graft in anenlarged bone (e.g. femoral) cavity. The device preferably includes abarrel pre-loaded with bone graft and a cannulated ejector positionedover a multi-section guide wire. This arrangement purports to accomplishboth ejecting bone graft from the barrel and compacting the bone graftmaterial while being guided on the guide wire. Mikhail, however, isdesigned solely for use with slurry-type bone graft, and does notaccommodate bone graft in granule form, which often varies in size amonggranules and does not have the same “flow” or viscosity characteristicsas slurry-type bone graft. Thus, the applicator of Mikhail isinsufficient for introducing most bone graft to a surgical site in apatient.

U.S. Pat. No. 6,019,765 issued to Thornhill et al. on Feb. 1, 2000(“Thornhill”) also teaches a bone graft delivery device and isincorporated herein by reference in its entirety. The bone graft deviceapplicator of Thornhill is used to apply bone graft to an artificialjoint without having to remove a previously implanted prosthesiscomponent. The applicator device includes a hollow tube with anactuation mechanism for discharging the bone graft from the device via anozzle coupled to a distal end of the tube. The bone graft deliverydevice of Thornhill may include various components for loading thedevice with the bone graft, and may further include a plurality ofnozzles each having a geometry suited for a particular application. LikeMikhail, the Thornhill delivery device is designed for use with boneslurry, and requires much custom instrumentation and different sizedparts to achieve success in many bone graft delivery applications, whichin turn increases the time to assemble and use the delivery device andmay create further problems during the surgical operation.

U.S. Pat. No. 5,697,932 issued to Smith et al. on Dec. 16, 1997(“Smith”) discloses yet another bone graft delivery system and methodand is incorporated herein by reference in its entirety. In Smith, ahollow tube of pre-loaded bone graft and a plunger are used tofacilitate delivery of the bone graft to a bone graft receiving area. Apositioning structure is provided on the plunger to maintain the plungerin a desirable position with respect to the hollow tube. Adjunctpositioning means may also be provided to ensure that the plungerremains in the desirable position during the packing of bone graft intothe bone graft receiving area. Like the devices of Thornhill andMikhail, the device disclosed by Smith is clearly designed solely forslurry type bone graft, and does not provide an effective opening forreceiving the desired amount of bone graft. Furthermore, the hollow tubeshown by Smith is narrow and does not have a footing or other apparatusassociated with the delivery device for preventing the device frompenetrating, for example, the abdominal region of a patient, which mayoccur during tamping or packing of the bone graft. This in turn maycause serious injury to a patient if not controlled, and for thesereasons the device of Smith is also insufficient for delivery of bonegraft to a surgical site.

Traditional devices for inserting a fusion cage or other medicalimplants into a patient's spine or other surgical area are distinct andseparate from traditional devices that deliver bone graft material tothe surgical site. For example, once an implant has been positioned,then bone growth material is packed into the internal cavity of thefusion cage. Also, sometimes the process is reversed, i.e., the bonegrowth is inserted first, and then the implant. These bone growthinducing substances come into immediate contact with the bone from thevertebral bone structures which project into the internal cavity throughthe apertures. Two devices are thus traditionally used to insert bonegraft material into a patient's spine and to position and insert afusion cage. These devices thus necessitate a disc space preparationfollowed by introduction of the biologic materials necessary to inducefusion and, in a separate step, application of a structural interbodyfusion cage.

The problems associated with separate administration of the biologicmaterial bone graft material and the insertion of a fusion cage includeapplying the graft material in the path of the cage, restricting andlimiting the biologic material dispersed within the disk space, andrequiring that the fusion cage be pushed back into the same place thatthe fusion material delivery device was, which can lead to additionaltrauma to the delicate nerve structures.

Fusion cages provide a space for inserting a bone graft between adjacentportions of bone. Such cages are often made of titanium and are hollow,threaded, and porous in order to allow a bone graft contained within theinterior of the cage of grow through the cage into adjacent vertebralbodies. Such cages are used to treat a variety of spinal disorders,including degenerative disc diseases such as Grade I or IIspondylolistheses of the lumbar spine.

Surgically implantable intervertebral fusion cages are well known in theart and have been actively used to perform spinal fusion procedures formany years. Their use became popularized during the mid 1990's with theintroduction of the BAK Device from the Zimmer Inc., a specificintervertebral fusion cage that has been implanted worldwide more thanany other intervertebral fusion cage system. The BAK system is afenestrated, threaded, cylindrical, titanium alloy device that iscapable of being implanted into a patient as described above through ananterior or posterior approach, and is indicated for cervical and lumbarspinal surgery. The BAK system typifies a spinal fusion cage in that itis a highly fenestrated, hollow structure that will fit between twovertebrae at the location of the intervertebral disc.

Spinal fusion cages may be placed in front of the spine, a procedureknown as anterior lumbar interbody fusion, or ALIF, or placed in back ofthe spine. The cages are generally inserted through a traditional openoperation, though laparoscopic or percutaneous insertion techniques mayalso be used. Cages may also be placed through a posterior lumbarinterbody fusion, or PLIF, technique, involving placement of the cagethrough a midline incision in the back, or through a direct lateralinterbody fusion, or D-LIF, technique, involving placement of the cagethrough an incision in the side.

A typical procedure for inserting a common threaded and impacted fusioncage is as follows. First, the disc space between two vertebrae of thelumbar spine is opened using a wedge or other device on a first side ofthe vertebrae. The disk space is then prepared to receive a fusion cage.Conventionally, a threaded cage is inserted into the bore and the wedgeis removed. A disk space at the first side of the vertebrae is thenprepared, and a second threaded fusion cage inserted into the bore.Alternatively, the disk space between adjacent vertebrae may simply becleared and a cage inserted therein. Often, only one cage is insertedobliquely into the disk space. Use of a threaded cage may be foregone infavor of a rectangular or pellet-shaped cage that is simply insertedinto the disk space. Lastly, bone graft material may be inserted intothe surgical area using separate tools and devices.

U.S. Pat. No. 4,743,256 issued to Brantigan (“Brantigan”) discloses atraditional spinal back surgical method involving the implantation of aspinal fusion cage. The cage surfaces are shaped to fit within preparedendplates of the vertebrae to integrate the implant with the vertebraeand to provide a permanent load-bearing strut for maintaining the discspace. Brantigan teaches that these cages typically consist of ahomogeneous nonresorbable material such as carbon-reinforced polymerssuch as polyether ether ketone (PEEK) or polyether ketone ether ketoneketone (“PEKEKK”). Although these cages have demonstrated an ability tofacilitate fusion, a sufficient fusion is sometimes not achieved betweenthe bone chips housed within the cage and the vertebral endplates. Inparticular, achieving a complete fusion in the middle portion of thecage has been particularly problematic. As shown in FIG. 6 herein, theupper U and lower L surfaces of these cages C have large transversepores P which facilitate bone ingrowth, and these pores lead to an innervoid space IVS which houses bone graft (not shown) which facilitates thedesired fusion. In any case, Brantigan teaches the separate process andprocedure for the insertion of a fusion cage and the insertion of bonegraft. Indeed, local bone graft harvested from the channel cuts into thevertebrae to receive the plug supplements the fusion.

U.S. Pat. Appl. Pub. 2007/0043442 of Abernathie et al. (“Abernathie”)discloses another traditional spinal surgical method involving theimplantation of a spinal fusion cage. Abernathie relates generally to animplantable device for promoting the fusion of adjacent bony structures,and a method of using the same. More specifically, Abernathie relates toan expandable fusion cage that may be inserted into an intervertebralspace, and a method of using the same. Abernathie includes an aperturein the fusion cage to allow bone growth therethrough, as a separateprocedure to the insertion of the fusion cage.

Traditional fusion cages are available in a variety of designs andcomposed of a variety of materials. The cages or plugs are commonly madeof an inert metal substrate such as stainless steel,cobalt-chromium-molybdenum alloys, titanium or the like having a porouscoating of metal particles of similar substrate metal, preferablytitanium or the like as disclosed, for example, in the Robert M. PilliarU.S. Pat. No. 3,855,638 issued Dec. 24, 1974 and U.S. Pat. No. 4,206,516issued Jun. 10, 1980. These plugs may take the form of flat sidedcubical or rectangular slabs, cylindrical rods, cruciform blocks, andthe like.

U.S. Pat. No. 5,906,616 issued to Pavlov et al. (“Pavlov”) discloses afusion cage of various cylindrical and conical shapes and a method ofinsertion. Like Brantigan, Pavlov teaches the separate process andprocedure for the insertion of a fusion cage and the insertion of bonegraft. U.S. Pat. No. 5,702,449 (“McKay”) discloses a spinal implantcomprising a cage made of a porous biocompatible material reinforced byan outer sleeve made of a second material which is relatively strongerunder the compressive load of the spine than the biocompatible material.U.S. Pat. No. 6,569,201 issued to Moumene et al. (“Moumene”) teaches abone fusion device having a structural bioresorbable layer disposed uponthe outer surface of a non-resorbable support. As the bioresorbablestructural layer resorbs over time, the load upon the bone graft housedwithin the non-resorbable support increases. Published PCT ApplicationNo. WO 99/08627 (“Gresser”) discloses a fully bioresorbable interbodyfusion device, as well as homogeneous composite devices containing atleast 25% resorbable materials. U.S. Pat. No. 7,867,277 issued to Tohmehdiscloses a spinal fusion implant of bullet shaped end.

U.S. Pat. No. 7,846,210 issued to Perez-Cruet et al. (“Perez-Cruet”)discloses an interbody device assembly consisting of a fusion device andan insertion device. The insertion device positions the fusion devicebetween two vertebrae, provides bone graft material, and then detachesfrom the fusion device, leaving the fusion device in place to restoredisc space height. However, the Perez-Cruet device is designed toreceive bone graft material from its insertion device and distribute thematerial away from the fusion device. In most embodiments of the fusiondevice, a center plate is positioned immediately downstream of thereceived bone graft material and directs the bone graft to opposingsides of the fusion device. (See, for example, FIG. 20 depicting plate308 directing bone graft material 392 along the exterior sides of thefusion device 302). As such, the Perez-Cruet fusion device is unlikelyto completely fill the areas near of its fusion cage and deliver bonegraft material to the surrounding bone graft site. Furthermore, none ofthe Perez-Cruet fusion device embodiments feature a defined interiorspace or a cage-style design. Indeed, the Perez-Cruet fusion deviceexplicitly teaches away from a contained-interior, fusion-cage-styledevice, asserting that its fusion device fills all of the disc space asopposed to a cage design, which contains the bone material. Furthermore,the Perez-Cruet does not feature a distal tip that functions toprecisely position the fusion device and stabilize the device duringdelivery of bone graft material.

U.S. Pat. No. 7,985,256 issued to Grotz et al. (“Grotz”) discloses anexpandable spinal implant for insertion between opposed vertebral endplates. The implant is a cylinder block of slave cylinders; a centralcavity between the cylinders receives bone graft material and pistonspositioned within the cylinders provide a corrective bone engagingsurface for expanding against a first vertebral end plate. The insertiontool used to place the spinal implant includes a handle and hollowinterior for housing hydraulic control lines and a bone graft supplyline. The Grotz system does not allow precise positioning or delivery ofbone graft material without an implant and requires a complex and bulkyinsertion tool.

U.S. Pat. Appl. Pub. 2010/0198140 to Lawson (“Lawson”) discloses a toolcomprising a cannula with an open slot at the distal end and a closedtip. Lawson's tool employs tamps to push bone aside and open up a voidfor filling; solid bone pellets are then rammed down the hollow interiorof the cannula by a tamper and delivered to the surgical site. Lawsondoes not allow precise positioning or delivery of viscous bone graftmaterial and has no capability to interconnect or integrate with animplant such as a bone graft fusion cage.

U.S. Pat. Appl. Pub. 2010/0262245 to Alfaro et al. (“Alfaro”) disclosesa delivery system for an intervertebral spacer and a bone graftingmaterial comprising a spacer disengagingly attached to a hollow handle.The handle comprises a chamber and bone grafting material-advancingmeans for introducing bone grafting material from the chamber into thespacer and the intervertebral spaces. The Alfaro system does not allowprecise positioning or delivery of bone graft material through a distaltip that precisely positions the fusion device and stabilizes the deviceduring delivery of bone graft material, and does not allow primarilylateral injection of bone graft fusion material.

The prior art bone graft delivery devices listed above typically mustcome pre-loaded with bone graft, or alternatively require constantloading (where permissible) in order to constantly have the desiredsupply of bone graft available. Moreover, these bone graft deliverydevices generally cannot handle particulate bone graft of varying orirregular particulate size. Furthermore, the prior art devices forinserting a fusion cage or other medical implant into a patient's spineor other surgical area are commonly distinct and separate fromtraditional devices that deliver bone graft material to the surgicalsite. As such, two devices are traditionally used to insert bone graftmaterial into a patient's spine and to position and insert a fusioncage. The problems associated with separate administration of thebiologic material bone graft material and the insertion of a fusion cageinclude applying the graft material in the path of the cage, restrictingand limiting the biologic material dispersed within the disk space, andrequiring that the fusion cage be pushed back into the same place thatthe fusion material delivery device was, which can lead to additionaltrauma to the delicate nerve structures. These problems can be a greatinconvenience, cause avoidable trauma to a patient and make these priorart devices unsuitable in many procedures.

Therefore, there is a long-felt need for an apparatus and methodintegrated precision delivery of bone graft material during theplacement of surgical cages or other medical implants in a patient'sspine. The present invention solves these needs. The present inventionallows biologic material to flow directly to the fusion cage and bedispersed within the disc space in a single step, and can precisely andsimply deliver particulate bone graft of varying or irregularparticulate size. Thus, the present invention allows application of bonegraft material through a detachable fusion cage, eliminates otherwiserestriction of the volume of biologic material that may be dispersedwithin the disk space, and eliminates the requirement that the fusioncage be pushed back into the same place that the fusion materialdelivery device was, which can lead to additional trauma to the delicatenerve structures.

SUMMARY OF THE INVENTION

Certain embodiments of the present disclosure relate to an apparatus andmethod for the integrated delivery of bone graft material during theplacement of surgical cages or other medical implants in a patient'sspine. The integrated fusion cage and delivery device (the “device”) iscomprised generally of a tubular member and a plunger for expelling bonegraft from the tubular member, through a surgical fusion cage, and intoa bone graft receiving area, then disengaging the fusion cage at thesurgical site in a human patient. Thus, the apparatus and method allowsthe biologic material to flow directly into and through the fusion cageand be dispersed within the disc space in a single step, and leave thedetachable fusion cage in the surgical area. In one embodiment, theintegrated fusion cage is an expandable integrated fusion cage. Otherembodiments and alternatives to this device are described in greaterdetail below.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the surgicalprocedures in which bone graft is used and to further describe thevarious tools and other apparatus commonly associated therewith: U.S.Pat. No. 6,309,395 to Smith et al.; U.S. Pat. No. 6,142,998 to Smith etal.; U.S. Pat. No. 7,014,640 to Kemppanien et al.; U.S. Pat. No.7,406,775 to Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson; U.S.Pat. No. 7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson; U.S.Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, et al.;U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to Cornwall,et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat. No. 6,328,738 toSuddaby; U.S. Pat. No. 6,290,724 to Marino; U.S. Pat. No. 6,113,602 toSand; U.S. Pat. No. 6,030,401 to Marino; U.S. Pat. No. 5,865,846 toBryan, et al.; U.S. Pat. No. 5,569,246 to Ojima, et al.; U.S. Pat. No.5,527,312 to Ray; and U.S. Pat. Appl. Pub. No. 2008/0255564 toMichelson.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the surgicalprocedures in which fusion cages are used and to further describe thevarious tools and other apparatus commonly associated therewith: U.S.Pat. No. 6,569,201 to Moumene et al.; U.S. Pat. No. 6,159,211 to Borianiet al.; U.S. Pat. No. 4,743,256 to Brantigan; U.S. Pat. Appl.2007/0043442 to Abernathie et al.; U.S. Pat. Nos. 3,855,638 and4,206,516 to Pilliar; U.S. Pat. No. 5,906,616 issued to Pavlov et al.;U.S. Pat. No. 5,702,449 to McKay; U.S. Pat. No. 6,569,201 to Moumene etal.; PCT Appl. No. WO 99/08627 to Gresser; U.S. Pat. Appl. Pub.2012/0022651 to Akyuz et al.; U.S. Pat. Appl. Pub. 2011/0015748 to Molzet al.; U.S. Pat. Appl. Pub. 2010/0249934 to Melkent; U.S. Pat. Appl.Pub. 2009/0187194 to Hamada; U.S. Pat. No. 7,867,277 issued to Tohmeh;U.S. Pat. No. 7,846,210 to Perez-Cruet et al.; U.S. Pat. No. 7,985,256issued to Grotz et al.; U.S. Pat. Appl. Pub. 2010/0198140 to Lawson; andU.S. Pat. Appl. Pub. 2010/0262245 to Alfaro et al.

By way of providing additional background and context, the followingreferences are also incorporated by reference in their entireties forthe purpose of explaining the nature of spinal fusion and devices andmethods commonly associated therewith: U.S. Pat. No. 7,595,043 issued toHedrick et al.; U.S. Pat. No. 6,890,728 to Dolecek et al.; U.S. Pat. No.7,364,657 to Mandrusov, and U.S. Pat. No. 8,088,163 to Kleiner.

In addition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith: U.S. Pat. No.D647,202 entitled “Bone Marrow Harvesting Device” to Scifert issued Oct.18, 2011; U.S. Pat. No. 7,897,164 entitled “Compositions and Methods forNucleus Pulposus Regeneration” to Seifert issued Mar. 1, 2011; US Pat.Appl. No. 2010/0112029 entitled “Compositions and Methods for NucleusPulposus Regeneration” to Scifert issued May 6, 2010; US Pat. Appl. No.2010/0021518 entitled “Foam Carrier for Bone Grafting” to Scifert issuedJan. 28, 2010; U.S. Pat. No. 7,824,703 entitled “Medical Implants withReservoir(s), and Materials Preparable From Same” to Scifert, et al.,issued Nov. 2, 2010; US Pat. Appl. No. 2006/0247791 entitled“Multi-Purpose Medical Implant Devices” to McKay, et al., issued Nov. 2,2006; US Pat. Appl. No. 2007/0225811 entitled “Conformable OrthopedicImplant” to Scifert, et al., issued Sep. 27, 2007; U.S. Pat. No.6,746,487 entitled “Intramedullary Trial Fixation Device” to Scifert, etal., issued Jun. 9, 2004; US Pat. Appl. No. 2013/0073041 entitled“Medical Implants With Reservoir(s), and Materials Preparable From Same”to Scifert et al., issued Mar. 21, 2013; US Pat. Appl. No. 2010/0266689entitled “Tissue Augmentation With Active Agent For Wound Healing” toSimonton et al., issued Oct. 21, 2010; US Pat. Application No.2011/0028393 entitled “Flowable Paste And Putty Bone Void Filler” toVickers et al., issued Feb. 3, 2011; US Pat. Appl. No. 2009/0099660entitled “Instrumentation To Facilitate Access Into The IntervertebralDisc Space And Introduction Of Materials Therein” to Scifert issued Apr.16, 2009; US Pat. Appl. No. 2011/0014587 entitled “System And Methods OfPreserving An Oral Socket” to Spagnoli et al., issued Jan. 20, 2011;U.S. Pat. No. 8,148,326 entitled “Flowable Carrier Matrix and Methodsfor Delivering to a Patient” to Beals et al., issued Apr. 3, 2012; USPat. Appl. No. 2008/0260598 entitled “Devices, Methods and Systems forHydrating a Medical Implant Material” to Gross et al., issued Oct. 23,2008; US Pat. Appl. No. 2007/0265632 entitled “Bone Cutting Template andMethod of Treating Bone Fractures” to Seifert et al., issued Nov. 15,2007; U.S. Pat. No. 8,293,232 entitled “Flowable Carrier Matrix andMethods for Delivering to a Patient” to Beals et al., issued Oct. 23,2012; U.S. Pat. No. 8,198,238 entitled “Flowable Carrier Matrix andMethods for Delivering to a Patient” to Beals et al., issued Jun. 12,2012; U.S. Pat. No. 7,939,092 entitled “Cohesive Osteogenic Putty andMaterials Therefor” to McKay et al., issued May 10, 2011; US Pat. Appl.No. 2007/0264300 entitled “Therapeutic Agent Carrier and Method ofTreating Bone Fractures” to Scifert et al., issued Nov. 15, 2007; USPat. Appl. No. 2011/0020768 entitled “Implantable Screw and System forSocket Preservation” to Spagnoli et al., issued Jan. 27, 2011; US Pat.Appl. No. 2012/0065687 entitled “Multi-Radius Vertebral Rod with aVarying Stiffness” to Ballard et al., issued Mar. 15, 2012; US Pat. No.2007/0225219 entitled “Intramedullary Drug Delivery Device and Method ofTreating Bone Fractures” to Boden et al., issued Sep. 27, 2007; U.S.Pat. No. 7,723,291 entitled “Release of BMP, Bioactive Agents and/orCells Via a Pump into a Carrier Matrix” to Beals et al., issued May 25,2010; U.S. Pat. No. 7,671,014 entitled “Flowable Carrier Matrix AndMethods For Delivering To A Patient” to Beals et al., issued Mar. 2,1010; U.S. Pat. No. 7,897,564 entitled “Flowable Carrier Matrix andMethods for Delivering to a Patient” to Beals et al., issued Mar. 1,2011; US Pat. Application No. 2011/0160777 entitled “System and Methodsof Maintaining Space for Augmentation of the Alveolar Ridge” to Spagnoliet al., issued Jun. 30, 2011; US Pat. Application No. 2009/0246244entitled “Malleable Multi-Component Implants and Materials Therefor” toMcKay et al., issued Oct. 1, 2009; US Pat. Application No. 2009/0246244entitled “Malleable Multi-Component Implants and Materials Therefor” toMcKay et al., issued Oct. 1, 2009; US Pat. No. 2013/0110169 entitled“Vertebral Rod System and Methods of Use” to Hynes, et al., issued May2, 2013; US Pat. Appl. No. 2011/0184412 entitled “Pre-AssembledConstruct With One Or More Non-Rotating Connectors For Insertion Into aPatient” to Scifert, et al., issued Jul. 28, 2011; U.S. Pat. No.7,964,208 entitled “System and Methods of Maintaining Space ForAugmentation of the Alveolar Ridge” to Spagnoli, et al., issued Jun. 21,2011; U.S. Pat. No. 8,080,521 entitled “Flowable Carrier Matrix andMethods for Delivering to a Patient” to Beals, et al., issued Dec. 20,2011; US Pat. Appl. No. 2009/0142385 entitled “Compositions for TreatingBone Defects” to Gross, et al., issued Jun. 4, 2009; U.S. Pat. No.7,578,820 entitled “Devices and Techniques for a Minimally Invasive DiscSpace Preparation and Implant Insertion” to Moore, et al., issued Aug.25, 2009; US Pat. Appl. No. 2010/0305575 entitled “Methods and Apparatusfor Performing Knee Arthroplasty” to Wilkinson, et al., issued Dec. 2,2010; US Pat. Appl. No. 2011/0021427 entitled “Biphasic CalciumPhosphate Cement for Drug Delivery” to Amsden, et al., issued Jan. 27,2011; US Pat. Appl. No. 2012/0259335 entitled “Patello-Femoral JointImplant and Instrumentation” to Scifert, et al., issued Oct. 11, 2012;US Pat. Appl. No. 2011/0106162 entitled “Composite Connecting Elementsfor Spinal Stabilization Systems” to Ballard, et al., issued May 5,2011; US Pat. Appl. No. 2004/0073314 entitled “Vertebral Body and DiscSpace Replacement Devices” to White, et al., issued Apr. 15, 2004; U.S.Pat. No. 7,513,901 entitled “Graft Syringe Assembly” to Scifert, et al.,issued Apr. 7, 2009; US Pat. Appl. No. 2010/0004752 entitled “VertebralBody and Disc Space Replacement Devices” to White, et al., issued Jan.7, 2010; U.S. Pat. No. 7,615,078 entitled “Vertebral Body and Disc SpaceReplacement Devices” to White, et al., issued Nov. 10, 2009; U.S. Pat.No. 6,991,653 entitled “Vertebral Body and Disc Space ReplacementDevices” to White, et al., issued Jan. 31, 2006; US Pat. Appl. No.2010/0331847 entitled “Methods and Apparatus for Performing KneeArthroplasty” to Wilkinson, et al., issued Dec. 30, 2010; US Pat. Appl.No. 2006/0116770 entitled “Vertebral Body and Disc Space ReplacementDevices” to White, et al., issued Jun. 1, 2006; and U.S. Pat. No.8,246,572 entitled “Bone Graft Applicator” to Cantor, et al., issuedAug. 21, 2012.

According to varying embodiments described herein, the present inventionis capable of integrated delivery of bone graft material during theplacement of surgical cages or other medical implants into a patient'sspine. The delivery of the bone graft material may be to any area of thebody, and in particular to the intervertebral joints of the spine, forachieving bone graft fusion. Also, the invention may be used in therepair of a bone joint or in connection with the implantation ofprosthetic devices in the body, including, by way of example but notlimitation, the hip, knee and a variety of spinal joints. Additionally,the present invention may be used in primary surgery, in which a bonegraft is being supplied to promote new bone growth or to reconstruct ajoint for the first time, as well as in revision surgery, in which afollow-up procedure is being performed in an area that has previouslybeen subject to one or more surgeries. Further, the invention may beused in any application where an implant and/or material is to bedelivered with precision to a confined area where access is restricted.

Although well suited for use in human patients, and although much of thediscussion of the present invention is directed toward use in humans,advantages offered by the present invention may be realized in theveterinary and scientific fields for the benefit and study of all typesof animals and biological systems. Additionally, although the fusioncages of the present invention are particularly well-suited forimplantation into the spinal column between two target vertebrae, andalthough much of the discussion of the present invention is directedtoward their use in spinal applications, advantages offered byembodiments of the present invention may also be realized byimplantation at other locations within a patient where the fusion of twoor more bony structures may be desired. As one of skill in the art willappreciate, the present invention has applications in the general fieldof skeletal repair and treatment, with particular application to thetreatment of spinal injuries and diseases. It should be appreciated,however that the principles of the present invention can also findapplication in other areas, specifically where there is a desire toconstrain added fluid material to particular regions. For example, thepresent invention finds application in methods where the objective is toconfine added material to predetermined areas of interest and toprohibit the undesired translocation of such material until an operationis complete and/or until a predetermined later time.

According to various embodiments of the present disclosure, one aspectof the invention is to provide an integrated fusion cage and graftdelivery device that comprises a tubular member, which is substantiallyhollow or contains at least one inner lumen and that has a generallyrectangular cross-sectional shape. This generally rectangularcross-sectional shape offers a larger amount of surface area throughwhich bone graft material may be inserted and ejected from the hollowtubular member. Furthermore, this generally rectangular shape is morecongruent with the size or shape of the annulotomy of most disc spaces,which frequently are accessed by a bone graft delivery device fordelivery of bone graft. However, as one skilled in the art wouldappreciate, the tool cross-section need not be limited to a generallyrectangular shape. For example, cross-sections of an oval shape or thosewith at least one defined angle to include obtuse, acute, and rightangles can provide a shape in some situations that is more congruentwith the size or shape of the annulotomy of a particular disc space. Asubstantially round shape may also be employed that provides the surgeonwith an indication of directional orientation.

The phrase “removably attached” and/or “detachable” is used herein toindicate an attachment of any sort that is readily releasable.

The phrase “integrated fusion cage”, “spinal fusion implant”,“biological implant” and/or “fusion cage” is used here to indicate abiological implant.

In various embodiments, the fusion cage may be designed in variableheights and lengths so that it fits snugly into the prepared disk space.

In one embodiment of the fusion cage, the fusion cage is of rectangularcross-section, such that one pair of opposite sides, for example aheight first pair of sides, has a dimension of approximately 8-14 mm,and a second pair of opposite sides, for example a length dimension, ofapproximately 22-36 mm. One skilled in the art will appreciate that theexact dimensions of the fusion cage may be adapted to conform toparticulars of the surgical site, for example, the relative sizingbetween the particular vertebrae in which bone graft material and/or afusion cage is to be inserted. In other embodiments of the fusion cage,the fusion cage is of a substantially cylindrical shape. For example, apreferred embodiment of a fusion cage for use in an ALIF procedure formsa substantially cylindrical shape, with a height of approximately 8-14mm and a diameter of less than about 36 millimeters. As another example,a preferred embodiment of a fusion cage for use in conjunction with avertebrectomy has a substantially cylindrical shape with a height equalto or greater than the height of the vertebra (or the collective heightof the vertebrae) it is intended to replace and a diameter of less thanabout 36 millimeters. Preferably, the separation “zone” between the cageand the hollow filling tube is at one end of the cage, preferably theend of the cage (when implanted) closer to the incision site.

A preferred method of using the integrated fusion cage and graftdelivery device comprises precisely inserting the integrated fusion cageand graft delivery device, in one or more of the embodiments containedherein, into the surgical area. The integrated fusion cage and graftdelivery device is then filled with bone graft material in its one ormore substantially hollow tubes, the one or more plungers are insertedinto the one or more hollow tubes, and the one or more plunger arepushed into the one or more hollow tubes, guided precisely as enabled bythe minimal profile of the device, therein controllably depositing thebone graft material into the surgical area through and into the surgicalimplant cage. The surgical implant device may then be selectablydetached from the integrated fusion cage and graft delivery device so asto remain at the surgical site.

Another method of using the integrated fusion cage and graft deliverydevice comprises inserting the integrated fusion cage and graft deliverydevice into a prepared disk space, such that the fusion cage portionfits snugly into the prepared disk space (the fusion cage is designed invariable heights and lengths so as to fit snugly into the prepared diskspace), pushing the plunger through the hollow shaft so as to pushbiological fusion material (e.g. bone graft) through the hollow shaft toflow the biological material through the fusion cage's open lateraland/or medial portals in communication with the hollow tube and plunger,thereby delivering biological material into the prepared disk space,after which the fusion cage is detached from the hollow tube and left inthe disk space. Thus, the fusion cage is left in the disk space with amaximum and/or optimal amount of biological material delivered withinthe fusion cage and/or surrounding the fusion cage in the disk space.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of receipt of anelectrical, mechanical, pneumatic, hydraulic or other communicationimparted by the user upon the plunger and/or hollow tube so as to detachthe fusion cage and thereby deposit the fusion cage into the surgicalarea.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a Luer taperor Luer fitting connection, such as in a Luer-Lok® or Luer-Slip®configuration or any other Luer taper or Luer fitting connectionconfiguration. For purposes of illustration, and without wishing to beheld to any one embodiment, the following U.S. Patent Application isincorporated herein by reference in order to provide an illustrative andenabling disclosure and general description of means to selectablydetach the fusion cage of the integrated fusion cage and graft deliverydevice: U.S. Patent Appl. No. 2009/0124980 to Chen.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a pedicledart by threadable rotation to achieve attachment, detachment, and axialmovement. Other ways include a quick key insertion, an external snapdetent, or magnetic attraction or any other structure. For purposes ofillustration, and without wishing to be held to any one embodiment, thefollowing U.S. Patent Application is incorporated herein by reference inorder to provide an illustrative and enabling disclosure and generaldescription of means to selectably detach the fusion cage of theintegrated fusion cage and graft delivery device: U.S. Patent Appl. No.2009/0187194 to Hamada.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of magnetism.More specifically, the detachable fusion cage can be made to feature amagnetic field pattern and a resulting force R that are adjustable andmay be of different character than the rest of the integrated fusioncage and graft delivery device. With permanent magnets, such adjustmentscan be made mechanically by orienting various permanent magnet polargeometries and corresponding shapes relative to one another. U.S. Pat.No. 5,595,563 to Moisdon describes further background regarding suchadjustment techniques, which is hereby incorporated by reference in itsentirety. Alternatively or additionally, electromagnets could be used incombination with permanent magnets to provide adjustability. In furtherembodiments, the magnets and corresponding fields and the resultantmagnetic field pattern can include both attraction forces from placementof opposite pole types in proximity to one another and repulsion forcesfrom placement of like pole types in proximity to one another. As usedherein, “repulsive magnetic force” or “repulsive force” refers to aforce resulting from the placement of like magnetic poles in proximityto one another either with or without attractive forces also beingpresent due to opposite magnetic poles being placed in proximity to oneanother, and further refers to any one of such forces when multipleinstances are present. U.S. Pat. No. 6,387,096 is cited as a source ofadditional information concerning repulsive forces that are providedtogether with attractive magnetic forces, which is hereby incorporatedby reference. In another alternative embodiment example, one or more ofsurfaces of the fusion cage are roughened or otherwise includebone-engaging structures to secure purchase with vertebral surfaces. Inyet other embodiments, the selectable detachable feature between thedetachable fusion cage and the integrated fusion cage and graft deliverydevice can include one or more tethers, cables, braids, wires, cords,bands, filaments, fibers, and/or sheets; a nonfabric tube comprised ofan organic polymer, metal, and/or composite; an accordion or bellowstube type that may or may not include a fabric, filamentous, fibrous,and/or woven structure; a combination of these, or such differentarrangement as would occur to one skilled in the art. Alternatively oradditionally, the selectable detachable feature between the detachablefusion cage and the integrated fusion cage and graft delivery device canbe arranged to present one or more openings between members or portions,where such openings extend between end portions of the fusion cage. Forpurposes of illustration, and without wishing to be held to any oneembodiment, the following U.S. Patent Application is incorporated hereinby reference in order to provide an illustrative and enabling disclosureand general description of means to selectably detach the fusion cage ofthe integrated fusion cage and graft delivery device: U.S. Patent Appl.No. 2011/0015748 to Molz et al.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of plasmatreatment. The term “plasma” in this context is an ionized gascontaining excited species such as ions, radicals, electrons andphotons. (Lunk and Schmid, Contrib. Plasma Phys., 28: 275 (1998)). Theterm “plasma treatment” refers to a protocol in which a surface ismodified using a plasma generated from process gases including, but notlimited to, O₂, He, N₂, Ar and N₂O. To excite the plasma, energy isapplied to the system through electrodes. This power may be alternatingcurrent (AC), direct current (DC), radiofrequency (RF), or microwavefrequency (MW). The plasma may be generated in a vacuum or atatmospheric pressure. The plasma can also be used to deposit polymeric,ceramic or metallic thin films onto surfaces (Ratner, Ultrathin Films(by Plasma deposition), 11 Polymeric Materials Encyclopedia 8444-8451,(1996)). Plasma treatment is an effective method to uniformly alter thesurface properties of substrates having different or unique size, shapeand geometry including but not limited to bone and bone compositematerials. Plasma Treatment may be employed to effect magneticproperties on elements of the integrated fusion cage and graft deliverydevice, or to provide selectable detachment of the fusion cage. Forpurposes of illustration, and without wishing to be held to any oneembodiment, the following U.S. Patent Application is incorporated hereinby reference in order to provide an illustrative and enabling disclosureand general description of means to selectably detach the fusion cage ofthe integrated fusion cage and graft delivery device: U.S. Pat. No.7,749,555 to Zanella et al.

One having skill in the art will appreciate that the fusion cage may beselectably detachable to the integrated fusion cage and graft deliverydevice, for example, by means that mechanically grasp the head, meansthat attach by vacuum, and means that attach by friction, or other meansknown to those of skill in the art for attaching the head of anapparatus to the shaft of an apparatus.

Another embodiment of the present invention provides an integratedfusion cage and graft delivery system, by which a hollow tube and/or ahollow tube/plunger assembly can be prepared prior to opening a patient,thus minimizing the overall impact of the grafting aspect of a surgicalimplantation or other procedure. Moreover, the hollow tube may be madeto be stored with bone graft in it for a period of time, whether thetube is made of plastic, metal or any other material. Depending upon thesurgical application, it may be desirable to only partially fill thetube for storage, so that a plunger can be at least partially insertedat the time of a surgery.

The present invention can be used in veterinary conditions, in thethoracic spine or can be used for insertion of a laterally based diskreplacement.

Thus, according to various embodiments of the present disclosure, amethod of introducing bone graft material to a desired operating site(“bone graft receiving area”) is provided by use of a hollow tubularmember comprising a generally rectangular cross-sectional area, wherebythe desired operating area is capable of receiving at least one plunger.The one or more plunger having at least one distal end which is designedto accommodate ejecting bone graft or other material to be inserted intothe joint space or between intervertebral members in a generally lateraldirection, as opposed to a generally longitudinal direction (in relationto the direction of the primary axis of the device).

One skilled in the art will appreciate that the distal end of thetubular device need not be limited to those specific embodimentsdescribed above. Other forms, shapes or designs that enable theforegoing aspects of the present invention are hereby incorporated intothis disclosure. Forms, shapes and designs that relate to the provisionof an end of a tubular device to perform lateral introduction of bone orbone substitute to an operating site are considered to be within thescope of the present disclosure.

One aspect of the present invention provides an integrated fusion cageand graft delivery device system for delivering bone graft, in apartially formed, fully formed or unformed condition to a bone graftreceiving area in a body.

In one embodiment, the device is configured to deliver bone graftmaterial substantially laterally from its delivery end, that issubstantially not in the axial direction but rather substantially fromthe side and/or in a radial direction. This is distinctly different thandevices that deliver bone graft material along their vertical axis, thatis, along or out their bottom end, and/or obstruct the user view of thebone graft and/or fusion cage delivery site, such as that of U.S. Pat.Appl. No. 2010/0087828 to Krueger et al (“Krueger”), U.S. Pat. Appl. No.2009/0264892 to Beyar et al (“Beyar”), U.S. Pat. Appl. No. 2007/0185496to Beckman et al (“Beckman”), U.S. Pat. Appl. No. 2009/0275995 toTruckai et al (“Truckai”) and U.S. Pat. Appl. No. 2006/0264964 toScifert et al (“Scifert”). Krueger, Beyar, Beckman, Truckai and Scifertare incorporated by reference in their entireties for all purposes.

In one embodiment, the device is configured to deliver bone graftmaterial so as to completely fill the defined interior of its fusioncage and subsequently deliver bone graft material to the surroundingbone graft site, rather than, for example, to contain the bone materialas are the fusion cage designs of U.S. Pat. No. 7,846,210 to Perez-Cruet(“Perez-Cruet”). Further, the fusion device of this application featuresa distal tip that functions to precisely position the fusion device andstabilize the device during delivery of bone graft material. Perez-Cruetis incorporated by reference in its entirety for all purposes. Inaddition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 4,863,476 toShepperd; U.S. Pat. No. 6,743,255 to Ferree; U.S. Pat. No. 6,773,460 toJackson; U.S. Pat. No. 6,835,206 to Jackson; U.S. Pat. No. 6,972,035 toMichelson; U.S. Pat. No. 7,771,473 to Thramann; U.S. Pat. No. 7,850,733to Baynham; U.S. Pat. No. 8,506,635 to Palmatier; U.S. Pat. No.8,556,979 to Glerum; U.S. Pat. No. 8,628,576 to Triplett; U.S. Pat. No.8,709,086 to Glerum; U.S. Pat. No. 8,715,351 to Pinto; U.S. Pat. No.8,753,347 to McCormack; U.S. Pat. No. 8,753,377 to McCormack; U.S.Design Pat. No. D708,323 to Reyes; U.S. Pat. No. 8,771,360 to Jimenez;U.S. Pat. No. 8,778,025 to Ragab; U.S. Pat. No. 8,778,027 to Medina;U.S. Pat. No. 8,808,383 to Kwak; U.S. Pat. No. 8,814,940 to Curran; U.S.Pat. No. 8,821,396 to Miles; U.S. Patent Application Publication No.2006/0142858 to Colleran; U.S. Patent Application Publication No.2008/0086142 to Kohm; U.S. Patent Application Publication No.2010/0286779 to Thibodean; U.S. Patent Application Publication No.2011/0301712 to Palmatier; U.S. Patent Application Publication No.2012/0022603 to Kirschman; U.S. Patent Application Publication No.2012/0035729 to Glerum; U.S. Patent Application Publication No.2012/0089185 to Gabelberger; U.S. Patent Application Publication No.2012/0123546 to Medina; U.S. Patent Application Publication No.2012/0197311 to Kirschman; U.S. Patent Application Publication No.2012/0215316 to Mohr; U.S. Patent Application Publication No.2013/0158664 to Palmatier; U.S. Patent Application Publication No.2013/0178940; U.S. Patent Application Publication No. 2014/0012383 toTriplett; U.S. Patent Application Publication No. 2014/0156006; U.S.Patent Application Publication No. 2014/0172103 to O'Neil; U.S. PatentApplication Publication No. 2014/0172106 to To; U.S. Patent ApplicationPublication No. 2014/0207239 to Barreiro; U.S. Patent ApplicationPublication No. 2014/0228955 to Weiman; U.S. Patent ApplicationPublication No. 2014/0236296 to Wagner; U.S. Patent ApplicationPublication No. 2014/0236297 to Iott; U.S. Patent ApplicationPublication No. 2014/0236298 to Pinto.

Furthermore, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 7,803,159 toPerez-Cruet et al.; U.S. Pat. No. 8,852,282 to Farley et al.; U.S. Pat.No. 8,858,598 to Seifert et al.; U.S. Pat. No. D714,933 to Kawamura;U.S. Pat. No. 8,795,366 to Varela; U.S. Pat. No. 8,852,244 to Simonson;U.S. Patent Application Publication No. 2012/0158146 to Glerum et al.;U.S. Pat. No. 8,852,242 to Morgenstern Lopez et al.; U.S. Pat. No.8,852,281 to Phelps; U.S. Pat. No. 8,840,668 to Donahoe et al.; U.S.Pat. No. 8,840,622 to Vellido et al.; U.S. Patent ApplicationPublication No. 2014/0257405; U.S. Patent Application Publication No.2014/0257490 to Himmelberger et al.; U.S. Pat. No. 8,828,019 to Raymondet al.; U.S. Patent Application Publication No. 2014/0288652 to Boehm etal.; U.S. Patent Application Publication No. 2014/0287055 to Kunjachan;U.S. Patent Application Publication No. 2014/0276896 to Harper; U.S.Patent Application Publication No. 2014/0277497 to Bennett et al.; U.S.Patent Application Publication No. 2012/0029635 to Schoenhoeffer et al.;U.S. Patent Application Publication No. 2014/0303675 to Mishra; U.S.Patent Application Publication No. 2014/0303731 to Glerum; U.S. PatentApplication Publication No. 2014/0303732 to Rhoda et al.; U.S. Pat. No.8,852,279 to Weiman; PCT Pub. WO 2012/031267 to Weiman; U.S. Pat. No.8,845,731 to Weiman; U.S. Pat. No. 8,845,732 to Weiman; U.S. Pat. No.8,845,734 to Weiman; U.S. Patent Application Publication No.2014/0296985 to Balasubramanian et al.; U.S. Patent ApplicationPublication No. 2014/0309268 to Arnou; U.S. Patent ApplicationPublication No. 2014/0309548 to Merz et al.; U.S. Patent ApplicationPublication No. 2014/0309697 to Iott et al.; U.S. Patent ApplicationPublication No. 2014/0309714 to Mercanzini et al.; U.S. Pat. No.8,282,683 to McLaughlin et al.; U.S. Pat. No. 8,591,585 to McLaughlin etal; U.S. Pat. No. 8,394,129 to Morgenstern Lopez et al.; U.S. PatentApplication Publication No. 2011/0208226 to Fatone et al.; U.S. PatentApplication Publication No. 2010/0114147 to Biyani; U.S. PatentApplication Publication No. 2011/0144687 to Kleiner; U.S. Pat. No.8,852,243 to Morgenstern Lopez et al.; U.S. Pat. No. 8,597,333 toMorgenstern Lopez et al.; U.S. Pat. No. 8,518,087 to Lopez et al.; U.S.Patent Application Publication No. 2012/0071981 to Farley et al.; U.S.Patent Application Publication No. 2013/0006366 to Farley et al.; U.S.Patent Application Publication No. 2012/0065613 to Pepper et al.; U.S.Patent Application Publication No. 2013/0006365 to Pepper et al.; U.S.Patent Application Publication No. 2011/0257478 to Kleiner et al.; U.S.Patent Application Publication No. 2009/0182429 to Humphreys et al.;U.S. Patent Application Publication No. 2005/0118550 to Turri; U.S.Patent Application Publication No. 2009/0292361 to Lopez; U.S. PatentApplication Publication No. 2011/0054538 to Zehavi et al.; U.S. PatentApplication Publication No. 2005/0080443 to Fallin et al.; U.S. Pat. No.8,778,025 to Ragab et al.; U.S. Pat. No. 8,628,576 to Triplett et al;U.S. Pat. No. 8,808,304 to Weiman, and U.S. Pat. No. 8,828,019 toRaymond.

All of the following U.S. patents are also incorporated herein byreference in their entirety: U.S. Pat. Nos. 6,595,998; 6,997,929;7,311,713; 7,749,255; 7,753,912; 7,780,734; 7,799,034; 7,875,078;7,931,688; 7,967,867; 8,075,623; 8,123,755; 8,142,437; 8,162,990;8,167,887; 8,197,544; 8,202,274; 8,206,395; 8,206,398; 8,317,802;8,337,531; 8,337,532; 8,337,562; 8,343,193; 8,349,014; 8,372,120;8,394,108; 8,414,622; 8,430,885; 8,439,929; 8,454,664; 8,475,500;8,512,383; 8,523,906; 8,529,627; 8,535,353; 8,562,654; 8,574,299;8,641,739; 8,657,826; 8,663,281; 8,715,351; 8,727,975; 8,828,019;8,845,640; 8,864,830; 8,900,313; 8,920,507; 8,974,464; 9,039,767;9,084,686; 9,095,446; 9,095,447; 9,101,488; 9,107,766; 9,113,962;9,114,026; 9,149,302; 9,174,147; 9,216,094; 9,226,777; 9,295,500;9,358,134; 9,381,094; 9,439,692; 9,439,783; 9,445,921; 9,456,830;9,480,578; 9,498,200; 9,498,347; 9,498,351; 9,517,140; 9,517,141;9,517,142; 9,545,250; 9,545,279; 9,545,313; 9,545,318; 9,610,175;9,629,668; 9,655,660; 9,655,743; 9,681,889; 9,687,360; 9,707,094;9,763,700; 9,861,395; 9,980,737; 9,993,353; U.S. Pat. Pub. 2014/0088712;U.S. Pat. Pub. 2014/0276581; U.S. Pat. Pub. 2014/0371721; U.S. Pat. Pub.2016/0296344; U.S. Pat. Pub. 2017/0367846; U.S. Pat. Pub. 2017/0354514.

In addition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 4,863,476 toShepperd; U.S. Pat. No. 6,743,255 to Ferree; U.S. Pat. No. 6,773,460 toJackson; U.S. Pat. No. 6,835,206 to Jackson; U.S. Pat. No. 6,972,035 toMichelson; U.S. Pat. No. 7,771,473 to Thramann; U.S. Pat. No. 7,850,733to Baynham; U.S. Pat. No. 8,506,635 to Palmatier; U.S. Pat. No.8,556,979 to Glerum; U.S. Pat. No. 8,628,576 to Triplett; U.S. Pat. No.8,709,086 to Glerum; U.S. Pat. No. 8,715,351 to Pinto; U.S. Pat. No.8,753,347 to McCormack; U.S. Pat. No. 8,753,377 to McCormack; U.S.Design Pat. No. D708,323 to Reyes; U.S. Pat. No. 8,771,360 to Jimenez;U.S. Pat. No. 8,778,025 to Ragab; U.S. Pat. No. 8,778,027 to Medina;U.S. Pat. No. 8,808,383 to Kwak; U.S. Pat. No. 8,814,940 to Curran; U.S.Pat. No. 8,821,396 to Miles; U.S. Patent Application Publication No.2006/0142858 to Colleran; U.S. Patent Application Publication No.2008/0086142 to Kohm; U.S. Patent Application Publication No.20100286779 to Thibodeau; U.S. Patent Application Publication No.20110301712 to Palmatier; U.S. Patent Application Publication No.20120022603 to Kirschman; U.S. Patent Application Publication No.20120035729 to Glerum; U.S. Patent Application Publication No.20120089185 to Gabelberger; U.S. Patent Application Publication No.20120123546 to Medina; U.S. Patent Application Publication No.20120197311 to Kirschman; U.S. Patent Application Publication No.20120215316 to Mohr; U.S. Patent Application Publication No. 20130158664to Palmatier; U.S. Patent Application Publication No. 20130178940; U.S.Patent Application Publication No. 20140012383 to Triplett; U.S. PatentApplication Publication No. 20140156006; U.S. Patent ApplicationPublication No. 20140172103 to O'Neil; U.S. Patent ApplicationPublication No. 20140172106 to To; U.S. Patent Application PublicationNo. 20140207239 to Barreiro; U.S. Patent Application Publication No.20140228955 to Weiman; U.S. Patent Application Publication No.20140236296 to Wagner; U.S. Patent Application Publication No.20140236297 to Iott; U.S. Patent Application Publication No. 20140236298to Pinto.

Furthermore, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 7,803,159 toPerez-Cruet et al.; U.S. Pat. No. 8,852,282 to Farley et al.; U.S. Pat.No. 8,858,598 to Seifert et al.; U.S. Pat. No. D714,933 to Kawamura;U.S. Pat. No. 8,795,366 to Varela; U.S. Pat. No. 8,852,244 to Simonson;U.S. Patent Application Publication No. 2012/0158146 to Glerum et al.;U.S. Pat. No. 8,852,242 to Morgenstern Lopez et al.; U.S. Pat. No.8,852,281 to Phelps; U.S. Pat. No. 8,840,668 to Donahoe et al.; U.S.Pat. No. 8,840,622 to Vellido et al.; U.S. Patent ApplicationPublication No. 20140257405; U.S. Patent Application Publication No.20140257490 to Himmelberger et al.; U.S. Pat. No. 8,828,019 to Raymondet al.; U.S. Patent Application Publication No. 20140288652 to Boehm etal.; U.S. Patent Application Publication No. 20140287055 to Kunjachan;U.S. Patent Application Publication No. 20140276896 to Harper; U.S.Patent Application Publication No. 20140277497 to Bennett et al.; U.S.Patent Application Publication No. 20120029635 to Schoenhoeffer et al.;U.S. Patent Application Publication No. 20140303675 to Mishra; U.S.Patent Application Publication No. 20140303731 to Glerum; U.S. PatentApplication Publication No. 20140303732 to Rhoda et al.; U.S. Pat. No.8,852,279 to Weiman; PCT WO2012031267 to Weiman; U.S. Pat. No. 8,845,731to Weiman; U.S. Pat. No. 8,845,732 to Weiman; U.S. Pat. No. 8,845,734 toWeiman; U.S. Patent Application Publication No. 20140296985 toBalasubramanian et al.; U.S. Patent Application Publication No.20140309268 to Arnou; U.S. Patent Application Publication No.20140309548 to Merz et al.; U.S. Patent Application Publication No.20140309697 to Iott et al.; U.S. Patent Application Publication No.20140309714 to Mercanzini et al.; U.S. Pat. No. 8,282,683 to McLaughlinet al.; U.S. Pat. No. 8,591,585 to McLaughlin et al; U.S. Pat. No.8,394,129 to Morgenstern Lopez et al.; U.S. Patent ApplicationPublication No. 20110208226 to Fatone et al.; U.S. Patent ApplicationPublication No. 20100114147 to Biyani; U.S. Patent ApplicationPublication No. 20110144687 to Kleiner; U.S. Pat. No. 8,852,243 toMorgenstern Lopez et al.; U.S. Pat. No. 8,597,333 to Morgenstern Lopezet al.; U.S. Pat. No. 8,518,087 to Lopez et al.; U.S. Patent ApplicationPublication No. 20120071981 to Farley et al.; U.S. Patent ApplicationPublication No. 20130006366 to Farley et al.; U.S. Patent ApplicationPublication No. 20120065613 to Pepper et al.; U.S. Patent ApplicationPublication No. 20130006365 to Pepper et al.; U.S. Patent ApplicationPublication No. 20110257478 to Kleiner et al.; U.S. Patent ApplicationPublication No. 20090182429 to Humphreys et al.; U.S. Patent ApplicationPublication No. 20050118550 to Turri; U.S. Patent ApplicationPublication No. 20090292361 to Lopez; U.S. Patent ApplicationPublication No. 20110054538 to Zehavi et al.; U.S. Patent ApplicationPublication No. 20050080443 to Fallin et al.; U.S. Pat. No. 8,778,025 toRagab et al.; U.S. Pat. No. 8,628,576 to Triplett et al; U.S. Pat. No.8,808,304 to Weiman, and U.S. Pat. No. 8,828,019 to Raymond.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may have various sizes. The sizes of the variouselements of embodiments of the present disclosure may be sized based onvarious factors including, for example, the anatomy of the implantpatient, the person or other device operating the apparatus, the implantlocation, physical features of the implant including, for example, with,length and thickness, and the size of operating site or the size of thesurgical tools being used with the device.

One or ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide the various aspects of the presentdisclosure. These materials may include, for example, stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. These materials may also include, for example, aspolyether ether ketone (PEEK), carbon fiber, ABS plastic, polyurethane,rubber, latex, synthetic rubber, and other fiber-encased resinousmaterials, synthetic materials, polymers, and natural materials. Theplunger element could be flexible, semi-rigid, or rigid and made ofmaterials such as stainless steel, titanium alloy, aluminum alloy,chromium alloy, and other metals or metal alloys. Similarly, the tubularelement could be flexible, semi-rigid, or rigid and made of materialssuch as stainless steel, titanium alloy, aluminum alloy, chromium alloy,and other metals or metal alloys. In certain embodiments, the plungerand hollow tube are composed of plastic and are intended for one useonly and then discarded. In another embodiment, some or all elements ofthe device, or portions of some or all of the elements, are luminescent.Also, in another embodiment, some or all elements of the device, orportions of some or all of the elements, include lighting elements. Inanother embodiment, the hollow tube and/or plunger are made of asubstantially transparent material and/or are rigidly opaque.

In one embodiment of the fusion cage, the fusion cage comprises apolymer, such as PEEK, titanium and composite materials.

In another embodiment, a method is provided for delivering graftmaterial into a surgical site. The method includes the steps of (a)providing a hollow tube configured to receive the graft material, thehollow tube having a longitudinal axis, a proximal end, a distal endwith at least one opening, and a lumen extending from the proximal endto the distal end; (b) releasably attaching an implant to the distal endof the hollow tube so as to communicate with the at least one opening inthe distal end of the hollow tube, the implant being configured toreceive the graft material delivered through the hollow tube; (c)placing the implant within the surgical site; (d) advancing the graftmaterial through the lumen of the hollow tube; (e) conveying graftmaterial through the at least one opening of the distal end of thehollow tube into an interior of the implant, whereby the implant is atleast substantially filled with the graft material; and (f) dischargingthe graft material through at least one opening in the implant into thesurgical site, whereby the surgical site is at least substantiallyfilled with the graft material.

In a further embodiment, a method is provided for delivering graftmaterial into a surgical site. The method includes the steps of (a)providing a hollow tube configured to receive the graft material, thehollow tube having a longitudinal axis, a proximal end, a distal endwith at least one opening, and a lumen extending from the proximal endto the distal end; (b) releasably attaching an implant to the distal endof the hollow tube so as to communicate with the at least one opening inthe distal end of the hollow tube, the implant being configured toreceive the graft material delivered through the hollow tube; (c)placing the implant within the surgical site; (d) providing a plungeradapted to travel in the lumen of the hollow tube, the plunger having ashaft and a distal portion configured to advance graft material alongthe longitudinal axis of the hollow tube; (e) advancing the graftmaterial through the lumen of the hollow tube using the plunger; (f)conveying the graft material through the at least one opening of thedistal end of the hollow tube into an interior of the implant; (g)discharging the graft material through at least one opening in theimplant into the surgical site; and (h) releasing the distal end of thehollow tube from the implant.

In a still further embodiment, a method is provided for delivering graftmaterial into a surgical site. The method includes the steps of (a)providing a hollow tube configured to receive the graft material, thehollow tube having a longitudinal axis, a proximal end, a distal endwith at least one opening, and a lumen extending from the proximal endto the distal end; (b) releasably attaching a fusion cage to the distalend of the hollow tube so as to communicate with the at least oneopening in the distal end of the hollow tube, the fusion cage beingconfigured to receive the graft material delivered through the hollowtube, and the fusion cage being configured to be expandable; (c) placingthe fusion cage within the surgical site; (d) expanding the fusion cagefrom an unexpanded state to an expanded state; (e) advancing the graftmaterial through the lumen of the hollow tube; (f) conveying the graftmaterial through the at least one opening of the distal end of thehollow tube into an interior of the fusion cage; (g) discharging thegraft material through at least one opening in the fusion cage into thesurgical site; and (h) releasing the distal end of the hollow tube fromthe fusion cage.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be controlled by means other than manualmanipulation. Embodiments of the present disclosure may be designed andshaped such that the apparatus may be controlled, for example, remotelyby an operator, remotely by an operator through a computer controller,by an operator using proportioning devices, programmatically by acomputer controller, by servo-controlled mechanisms, byhydraulically-driven mechanisms, by pneumatically-driven mechanisms orby piezoelectric actuators.

Embodiments of the present disclosure present several advantages overthe prior art including, for example, the speed of the procedure, theminimally invasive aspect of the procedure, the ability to introduce theimplant material to the implant site with minimal risk and damage to thesurrounding tissue, the lower risk of infection, more optimally placedimplant material, a more stable delivery device which is designed toreduce the likelihood of the implant material becoming dislodged priorto fixation, and fewer tools in a surgical site due to the integrationof several components required to provide bone graft to a bone graftreceiving area. Further, the lower profile of the device allows improvedviewing of the area intended for receipt of bone graft material, and useof a reduced set and size of elements therein provided a less expensivedevice. Also, the device disclosed provides that substantially all ofthe bone graft material may be ejected from the device and delivered tothe surgical site, rather than wasted as unretrievable matter remaininginside the device. The ability to remove substantially all of the bonegraft material is of significant benefit because the bone graft materialis expensive and/or hard to obtain.

This Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description of the Invention, and nolimitation as to the scope of the present disclosure is intended byeither the inclusion or non-inclusion of elements, components, etc. inthis Summary of the Invention. Additional aspects of the presentdisclosure will become more readily apparent from the DetailedDescription, particularly when taken together with the drawings.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.However, the Detailed Description of the Invention, the drawing figures,and the claims set forth herein, taken in conjunction with this Summaryof the Invention, define the invention. The above-described benefits,embodiments, and/or characterizations are not necessarily complete orexhaustive, and in particular, as to the patentable subject matterdisclosed herein. Other benefits, embodiments, and/or characterizationsof the present disclosure are possible utilizing, alone or incombination, as set forth above and/or described in the accompanyingfigures and/or in the description herein below. However, the DetailedDescription of the Invention, the drawing figures, and the claims setforth herein, taken in conjunction with this Summary of the Invention,define the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

FIG. 1A is a front perspective view of the device for delivering bonegraft;

FIG. 1B is a front perspective view of the plunger of the device;

FIG. 1C is a cross sectional view of a portion of the device shown inFIG. 1A;

FIG. 2 is another front perspective view of the device of FIGS. 1A and1B, showing the relationship between the tubular and plunger portions ofthe device;

FIG. 3 is a front perspective view of the device according to onealternative embodiment where the tubular portion includes a foot sectionand where the plunger portion has been fully inserted into the tubularportion;

FIG. 4 is a partial front perspective view of another alternativeembodiment of the device where the tubular portion includes a funnel atits proximal end designed to receive bone graft;

FIG. 5 is a partial front perspective view of the device according toone embodiment where the device is positioned in a disc space during asurgical operation;

FIG. 6 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember;

FIG. 7 is another front perspective view of the tubular portion of thedevice of FIG. 6 showing the second of two lateral openings at thedistal end of the tubular portion and a wedge-shaped distal end of thetubular member;

FIG. 8 is a front elevation view of the distal end of the tubularportion of the device of FIG. 6;

FIG. 9 is a bottom elevation view of the proximal end of the tubulardevice of FIG. 6;

FIG. 10A is a top plan view of the device of FIG. 6 with the plungerportion fully inserted into the tubular portion;

FIG. 10B is a left elevation view of the device of FIG. 6 with theplunger portion fully inserted into the tubular portion;

FIG. 10C is a bottom plan view of the device of FIG. 6 with the plungerportion fully inserted into the tubular portion;

FIG. 10D is a right elevation view of the device of FIG. 6 with theplunger portion fully inserted into the tubular portion;

FIG. 11A is a front perspective view of one embodiment of the fusioncage of the device, showing a tapered proximal end and medial openings;

FIG. 11B is a top plan view of the fusion cage of FIG. 11A;

FIG. 11C is a left elevation view of the fusion cage of FIG. 11A;

FIG. 11D is a rear elevation view of the fusion cage of FIG. 11A;

FIG. 12A is a front perspective view of another embodiment of the fusioncage of the device;

FIG. 12B is a front perspective view of yet another embodiment of thefusion cage of the device;

FIG. 12C is a front perspective view of yet another embodiment of thefusion cage of the device;

FIG. 13 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember, and a fusion cage fitting over the exterior distal end of thetubular member;

FIG. 14A is a top plan view of the device of FIG. 13 with the plungerportion fully inserted into the tubular portion and the fusion cagefully inserted over the tubular portion;

FIG. 14B is a left elevation view of the device of FIG. 13 with theplunger portion fully inserted into the tubular portion and the fusioncage fully inserted over the tubular portion;

FIG. 14C is a bottom plan view of the device of FIG. 13 with the plungerportion fully inserted into the tubular portion and the fusion cagefully inserted over the tubular portion;

FIG. 14D is a right elevation view of the device of FIG. 13 with theplunger portion fully inserted into the tubular portion and the fusioncage fully inserted over the tubular portion;

FIG. 15A is a front perspective view of another embodiment of the fusioncage of the device;

FIG. 15B is a top plan view of another embodiment of the device whereinthe fusion cage of the device includes internal ramps and locking slotsconfigured to engage locking tabs of the tubular portion, and theplunger includes a tapered tip;

FIG. 15C is a left elevation view of the fusion cage of FIG. 15B;

FIG. 15D is a front elevation view of the tubular portion of FIG. 15B;

FIG. 16 is a top plan view of another embodiment of the device with theplunger portion partial inserted into the tubular portion and the fusioncage engaged with the tubular portion via a break-off collar;

FIG. 17A is a top plan view of another embodiment of the device whereinthe fusion cage engages with a connector conduit which in turn engageswith the tubular portion;

FIG. 17B is a cross-sectional view of section A-A of FIG. 17A;

FIG. 18A is a top plan view of another embodiment of the device whereinthe tubular portion comprises a telescoping feature;

FIG. 18B is a left elevation view of the device of FIG. 18A;

FIG. 18C is a bottom plan view of the device of FIG. 18A;

FIG. 18D is a right elevation view of the device of FIG. 18A;

FIG. 19A is a top plan view of a fusion cage of an embodiment of thedevice particularly adapted for use in anterior lumbar interbody fusionprocedures;

FIG. 19B is a front elevation view of the device of FIG. 19A;

FIG. 19C is a left elevation view of the device of FIG. 19A;

FIG. 19D is a view of the device of FIG. 19A inserted between vertebrae;

FIG. 20A is a cross-sectional top plan view of a fusion cage of anembodiment of the device particularly adapted for use in direct lateralinterbody fusion procedures;

FIG. 20B is a front elevation view of the device of FIG. 20A;

FIG. 20C is a left elevation view of the device of FIG. 20A;

FIG. 20D is a view of the device of FIG. 20A inserted between vertebrae;

FIG. 21A is a front perspective view of a fusion cage of an embodimentof the device particularly adapted for use in connection withvertebrectomy procedures;

FIG. 21B is a left perspective view of the device of FIG. 21A;

FIG. 21C is a front elevation view of the device of FIG. 21A insertedinto a surgical site;

FIG. 21D is a left elevation view of the device of FIG. 21A insertedinto a surgical site;

FIG. 22 is a front perspective view of another embodiment of the devicefor delivering bone graft;

FIG. 23 is a front perspective exploded view of the device shown in FIG.22;

FIG. 24 is a top plan view of the device shown in FIG. 22;

FIG. 25 is a front elevation view of the device shown in FIG. 22;

FIG. 26 is a right elevation view of the device shown in FIG. 22;

FIG. 27 is a bottom plan view of the device shown in FIG. 22;

FIG. 28 is a cross-sectional view of section A-A of FIG. 25;

FIG. 29 is a front elevation view of the plunger element of the deviceshown in FIG. 22;

FIG. 30 is a cross-sectional view of section B-B of FIG. 29;

FIG. 31 is a cross-sectional of section C-C of FIG. 29;

FIG. 32 is a detailed front perspective view of a portion of the deviceshown in FIG. 22;

FIG. 33 is a cross-sectional view of section D-D of FIG. 32;

FIG. 34A is a bar graph describing experimental results of bone graftdelivery and disk material removed for L4-5;

FIG. 34B is a bar graph describing experimental results of bone graftdelivery and disk material removed for L5-S1;

FIG. 35A is a table describing experimental results of bone graftdelivery and disk material removed;

FIG. 35B is a graph of the table of FIG. 35A describing experimentalresults of bone graft delivery and disk material removed;

FIG. 36 is a front perspective exploded view of an integrated fusioncage and graft delivery device according to another embodiment;

FIG. 37 is a front perspective view of the device of FIG. 36;

FIG. 38 is a closed-up front perspective view of the device of FIG. 36;

FIG. 39 is a front perspective view of the ejection tool element of thedevice of FIG. 36;

FIG. 40 is a front perspective view of an integrated fusion cage andgraft delivery device according to yet another embodiment;

FIG. 41 is a closed-up front perspective view of the device of FIG. 40;

FIG. 42 is a close-up front perspective view of the ejection toolelement first end;

FIG. 43 is a cut-away cross-sectional view of the element of FIG. 42;

FIG. 44 is a close-up cut-away cross-sectional view of one embodiment ofthe integrated fusion cage and graft delivery device;

FIGS. 45A-G provide scaled views of one embodiment of the fusion cageelement of yet another embodiment of the integrated fusion cage andgraft delivery device configured to operate with the hollow tube ofFIGS. 46A-H, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E;

FIGS. 46A-H provide scaled views of one embodiment of the hollow tube(aka snap on cannula) of the integrated fusion cage and graft deliverydevice configured to operate with the fusion cage element of FIGS.45A-G, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E;

FIGS. 47A-D provide scaled views of one embodiment of the plunger (akasnap on plunger) of the integrated fusion cage and graft delivery deviceconfigured to operate with the fusion cage element of FIGS. 45A-G,hollow tube of FIGS. 46A-H, and ejection tool of FIGS. 48A-E;

FIGS. 48A-E provide scaled views of one embodiment of the ejection tool(aka cage insertion tool) of the integrated fusion cage and graftdelivery device configured to operate with the fusion cage element ofFIGS. 45A-G, hollow tube of FIGS. 46A-H and plunger of FIGS. 47A-D;

FIG. 49A is a left perspective view of an embodiment of the fusion cagewith expandable fusion cage feature, the fusion cage in an unexpandedstate;

FIG. 49B is a rear perspective view of the device shown in FIG. 49A;

FIG. 49C is a top perspective view of the device shown in FIG. 49A;

FIG. 50A is a left perspective view of the device shown in FIG. 49A, thefusion cage in an expanded state;

FIG. 50B is a rear perspective view of the device shown in FIG. 50A;

FIG. 50C is a top perspective view of the device shown in FIG. 50A;

FIG. 51 is a scaled rear perspective exploded view of an embodiment ofthe fusion cage with expandable fusion cage feature;

FIGS. 52A-E provide scaled views of the device shown in FIG. 51, thefusion cage in an unexpanded state;

FIGS. 53A-E provide scaled views of the device shown in FIG. 51, thefusion cage in an expanded state;

FIGS. 54A-F provide scaled views of the upper plate component of thedevice shown in FIG. 51;

FIGS. 55A-E provide scaled views of the front block component of thedevice shown in FIG. 51;

FIGS. 56A-F provide scaled views of the rear block component of thedevice shown in FIG. 51;

FIGS. 57A-C provide scaled views of the expansion screw component of thedevice shown in FIG. 51;

FIG. 58 is a rear perspective exploded view of another embodiment of thefusion cage with expandable fusion cage feature;

FIGS. 59A-E provide scaled views of the device shown in FIG. 58, thefusion cage in an unexpanded state;

FIGS. 60A-E provide scaled views of the device shown in FIG. 58, thefusion cage in an expanded state;

FIG. 61A is a front left perspective view of yet another embodiment ofthe fusion cage with expandable fusion cage feature, comprising avertical wedge angle α feature;

FIG. 61B is a left elevation view of the device of FIG. 61A;

FIG. 62A is a front left perspective view of yet another embodiment ofthe fusion cage with expandable fusion cage feature, comprising ahorizontal wedge angle β feature;

FIG. 62B is a left elevation view of the device of FIG. 62A;

FIG. 63A is a left rear perspective view of a fusion cage withexpandable fusion cage feature configured to communicate with aninstaller/impactor component according to yet another embodiment;

FIG. 63B is a close-up partial left rear perspective view of the devicesof FIG. 63A;

FIG. 64 is a left rear perspective view of the rear block component ofthe fusion cage of FIG. 63A;

FIG. 65A is a left rear perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, and the installer/impactor comprising aninstaller/impactor handle;

FIG. 65B is a left front perspective partial cross-sectional view of thedevices of FIG. 63A in the state of FIG. 65A, shown with the fusion cageand installer/impactor components in an engaged state, the devicesengaged with an expansion driver component, the installer/impactorcomponent shown in partial cross-section to partially show the expansiondriver fitted within the interior of the installer/impactor;

FIG. 66 is a left front perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, with the hollow tube component engaged with theinstaller/impactor component;

FIG. 67 is a left rear perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, and shown with the fusion cage and hollow tube in anengaged state;

FIG. 68A is a left rear perspective view of the devices of FIG. 63A,shown in the configuration of FIG. 67, with a removal pliers componentengaged with the hollow tube component;

FIG. 68B is a close-up partial perspective view of the devices of FIG.68A;

FIG. 69 is a left rear exploded perspective view of a fusion cage withexpandable fusion cage feature engaged with a hollow tube component anda funnel component, as configured to engage with a plunger component;

FIG. 70 is a left front partial perspective view of another embodimentof the hollow tube component configured to engage a fusion cage withexpandable fusion cage feature, the hollow tube configured with hollowtube slot and hollow tube slot aperture features;

FIG. 71 is a left rear perspective view of another embodiment of thelower plate component of a fusion cage with expandable fusion cagefeature, the lower plate configured with a plate tab feature configuredto engage the hollow tube slot and hollow tube slot aperture features ofFIG. 70;

FIG. 72 is a left front partial cross-section perspective view of thedevices of FIGS. 70 and 71, shown with the plate tab feature engagedwith the hollow tube slot and hollow tube slot aperture features;

FIG. 73 is a right rear exploded view of another embodiment of thefusion cage with expandable cage feature;

FIG. 74 depicts the fusion cage with expandable cage feature engagedwith an angled insertion tool.

FIG. 75A is a perspective view of a device for delivering bone graft ofanother embodiment illustrating a hollow tubular member including aplurality of vent ports and a plunger of an embodiment of the presentdisclosure;

FIG. 75B is a top plan view of the hollow tubular member of FIG. 75A anddetachable funnel;

FIG. 75C is a side elevation view of the hollow tubular member of FIG.75A interconnected to the funnel and including a plunger inserted into alumen of the hollow tubular member;

FIG. 75D is a front elevation view of the hollow tubular member of FIG.75A and illustrating an optional opening at the distal end;

FIG. 75E is an expanded cross sectional view of a portion of the hollowtubular member;

FIG. 75F illustrates devices used to prepare bone graft materialaccording to one embodiment of the present disclosure;

FIG. 75G is a cross-sectional view of a surgical site and a bone graftdelivery device according to one embodiment of the present disclosure;

FIG. 76 is a cross-sectional view of an intervertebral disc space and abone graft delivery device;

FIG. 77A is a cross-sectional view of a surgical site and a bone graftdelivery device according to one embodiment of the present disclosure;

FIG. 77B another cross-sectional view of the surgical site of FIG. 77Aafter the bone graft delivery device has been removed therefrom;

FIG. 78 is a side perspective view of another embodiment of a device fordelivering bone graft; and

FIG. 79 is a side perspective view of still another integrated fusioncage and graft delivery device of the present disclosure.

To provide further clarity to the Detailed Description provided hereinin the associated drawings, the following list of components andassociated numbering are provided as follows:

-   -   1 Integrated fusion cage and graft delivery device    -   2 Hollow tube    -   3 Hollow tube first (side) exterior surface    -   4 Opening (of Hollow tube)    -   5 Hollow tube second (top) exterior surface    -   6 First (or proximal) end (of Hollow tube)    -   6A Knob    -   6B Pin    -   7 Hollow tube first distal opening    -   7A opening    -   7B opening    -   7C opening    -   8 Second (or distal) end (of Hollow tube)    -   8A Hollow tube cage clamp    -   8B Hollow tube cage clamp radial surface    -   9 Hollow tube distal interior ramp    -   9A Hollow tube distal interior ramp surface    -   10 Curved surface (of Hollow tube)    -   10A Curved interior surface (of Hollow tube)    -   11 Footing (of Hollow tube)    -   12 Plunger    -   13 Plunger distal first surface    -   14 Plunger distal second surface    -   15 Plunger distal third surface    -   16 Handle (of Plunger)    -   16A Plunger stop    -   17 Plunger medial portion    -   18 Second (or distal) end (of Plunger)    -   18A Pusher    -   19 Horizontal surface (of Plunger)    -   20 Curved surface (of Plunger)    -   21 Vent port    -   21A first vent port    -   21B second vent port    -   21C third vent port    -   22 First portion    -   23 Second portion    -   24 Joint or plane    -   25 Peg or pin    -   26 Recess    -   27 Teeth or notches of plunger    -   28 Lumen    -   29 Indicia to indicate depth of insertion of distal end    -   30 Funnel    -   32 Sleeve (of Funnel)    -   33 Slot for pin of bayonet mount    -   34 Opening (of Funnel)    -   35 Vent channel in plunger pusher    -   36 Endoscope, camera, or image sensing device    -   37 Lighting element    -   40 Disc space    -   42 Syringe    -   42A First Device (syringe)    -   42B Second Device (syringe)    -   44 Bone graft material    -   44A First bone graft component    -   44B Second bone graft component    -   46 Luer lock device    -   48 Bore    -   50 Wedge-shaped Second/distal end (of Hollow tube)    -   52 Wedge-shaped Second end (of Plunger)    -   60 Fusion Cage    -   61 Fusion cage surface texture    -   62 Fusion Cage First End    -   64 Fusion Cage Second (or Distal) End    -   65 Fusion Cage First Opening Pair    -   66 Fusion Cage First End Opening    -   67 Fusion Cage Second Opening Pair    -   68 Fusion Cage Medial Opening    -   69 Fusion Cage Lateral Opening    -   70 Fusion Cage Medial Surfaces    -   72 Fusion Cage Internal Ramps    -   80 Hollow Tube Locking Tabs    -   82 Fusion Cage Locking Slots    -   90 Break-off Collar    -   92 Fusion Cage Collar    -   93 Fusion Cage Collar Face    -   94 Fusion Cage Collar Cavity    -   96 Fusion Cage Tab Extension    -   97 Fusion Cage Tab Extension Latch    -   100 Connector Conduit    -   102 Connectors    -   106A Collar    -   106B Projection    -   110 ALIF Fusion Cage    -   112 ALIF Fusion Cage Portals    -   114 ALIF Fusion Cage Chamber    -   116 ALIF Fusion Cage Break-off Collar    -   120 D-LIF Fusion Cage    -   122 D-LIF Fusion Cage Portals    -   124 D-LIF Fusion Cage Chamber    -   126 D-LIF Fusion Cage Break-off Collar    -   130 Vertebrectomy Fusion Cage    -   132 Vertebrectomy Fusion Cage Porous Wall Portion    -   134 Vertebrectomy Fusion Cage Chamber    -   136 Vertebrectomy Fusion Cage Break-off Collar    -   138 Vertebrectomy Fusion Cage Impervious Wall Portion    -   140 Ejection Tool    -   142 Ejection Tool First (Proximal) End    -   143 Ejection Tool Stop    -   144 Ejection Tool Cover    -   145 Ejection Tool Cover Cavity    -   146 Spring Cover    -   147 Spring Cover Attachment    -   148 Spring    -   149 Ejection Tool Wings    -   150 Ejection Tool Wings Cavity    -   151 Ejection Tool L-cut    -   152 Ejection Tool Second (Distal) End    -   160 Ejection Tool Rod    -   170 Bone graft deliver device    -   171 Spine    -   172 Surgical site    -   172A Disc space    -   174 Path for fusion cage    -   200 Upper Plate    -   201 Upper Plate Front    -   202 Upper Plate Rear    -   203 Upper Plate Opening    -   204 Upper Plate Surface Texture    -   205 Upper Plate Track    -   206 Upper Plate Slot    -   209 Upper Plate Ridge    -   210 Lower Plate    -   211 Lower Plate Front    -   212 Lower Plate Rear    -   213 Lower Plate Opening    -   214 Lower Plate Surface Texture    -   215 Lower Plate Track    -   216 Lower Plate Slot    -   217 Plate Tab    -   218 Plate Nose    -   219 Lower Plate Ridge    -   220 Front Block    -   222 Front Block Upper Rail    -   224 Front Block Lower Rail    -   225 Front Block Nose    -   226 Front Block Ramp    -   227 Front Block Aperture    -   228 Block Spine    -   230 Rear Block    -   231 Rear Block Groove    -   232 Rear Block Upper Rail    -   234 Rear Block Lower Rail    -   236 Rear Block Ramp    -   237 Rear Block Aperture    -   238 Rear Block Aft    -   239 Rear Block Detent    -   240 Expansion Screw    -   242 Expansion Screw Head    -   244 Expansion Screw Tip    -   246 Expansion Screw Disk    -   250 Installer/Impactor    -   252 Installer/Impactor Tip    -   253 Installer/Impactor Aperture    -   254 Installer/Impactor Ridge    -   255 Installer/Impactor Channel    -   256 Installer/Impactor Ramp    -   258 Installer/Impactor Handle    -   260 Expansion Driver    -   268 Expansion Driver Handle    -   270 Removal Pliers    -   280 Hollow Tube External Ramp    -   282 Hollow Tube Notch    -   284 Hollow Tube Slot    -   285 Hollow Tube Slot Aperture    -   290 Cam    -   292 Nose Cone    -   294 Ramps    -   300 Adaptor    -   304 Grip    -   306 Trigger    -   308 Handle    -   310 Knob    -   312 Switch or button    -   314 Loading port    -   316 Capsule or package of bone graft material    -   318 Knob of grip    -   320 Flange    -   322 Slot    -   324 Channel    -   326 Proximal opening of channel    -   400 Prior Art Fusion Cage    -   400′ Modified Prior Art Fusion Cage    -   A Height of Opening (in Hollow tube)    -   B Width of Opening (in Hollow tube)

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to a device and method for integrateddelivery of bone graft material and a fusion cage to any portion of apatient which requires bone graft material and/or a fusion cage. Thus,for example, the foregoing description of the various embodimentscontemplates delivery to, for example, a window cut in a bone, whereaccess to such window for bone grafting is difficult to obtain becauseof orientation of such window, presence of muscle tissue, risk of injuryor infection, etc. The integrated fusion cage and graft delivery deviceis formed such that the one or more hollow tubes and/or plungers may behelpful in selectively and controllably placing bone graft material anda fusion cage in or adjacent to such window. The integrated fusion cageand graft delivery device is formed to allow delivery of bone graftmaterial and/or a fusion cage in a direction other than solely along thelongitudinal axis of the device, and in some embodiments transverse tothe primary axis used by the surgeon or operator of the device wheninserting the device into a cannula or other conduit to access thesurgical site. This same concept applies to other areas of a patient,whether or not a window has been cut in a bone, for example in avertebral disc space, and may be used whether this is a first surgery tothe area or a follow-up surgery. The present invention also contemplatesthe delivery of bone graft material and/or a fusion cage with or withoutthe use of a plunger, and with or without the use of various other toolsdescribed in greater detail herein.

Referring now to FIGS. 1-33 and 36-45, several embodiments of thepresent invention are shown.

In regard to FIG. 1A, an integrated fusion cage and graft deliverydevice portion is shown, which is comprised of a hollow tubular memberor hollow tube or contains at least one inner lumen 2, which has a firstproximate end 6 (which is referred to elsewhere in this specification asthe “graspable end” of hollow tube 2), and a second distal end 8, with ageneral hollow structure therebetween. Thus, as shown in FIG. 1, thehollow tube 2 allows bone graft material to be inserted into the opening4 at the graspable end 6 of the hollow tube 2, and ultimately exitedfrom the hollow tube 2 through the second end 8. According to apreferred embodiment, the hollow tube 2 also comprises at least onesloped or curved surface 10 at or near the second end 8 of the hollowtube 2. Although a generally rectangular cross-section is depicted, thecross-section need not be limited to a generally rectangular shape. Forexample, cross-sections of an oval shape or those with at least onedefined angle to include obtuse, acute, and right angles can provide ashape in some situations that is more congruent with the size or shapeof the annulotomy of a particular disc space.

Referring now in detail to FIG. 1B, a plunger 12 is shown for use withthe hollow tube 2 of FIG. 1A. The plunger 12 is generally of the samegeometry as the hollow portion of the hollow tube 2, extending at leastthe same length of hollow tube 2. The plunger 12 may include, asdepicted in FIG. 1B, at least one knob or handle 16 for grasping by auser of the plunger 12. As with the interior of the hollow tube 2 at itssecond end 8, the plunger 12 also comprises at least one sloped orcurved surface 20 at or adjacent to a second end 18 of the plunger 12.The plunger 12 terminates in a generally flat, horizontal surface 19,which corresponds to the opening at the second end 8 of the hollow tube2 shown in FIG. 1A. Thus, in cooperation, the plunger 12 may be insertedinto the opening 4 of the hollow tube 2 shown in FIG. 1A, and extendedthe entire length of the hollow tube 2, at least to a point where thehorizontal surface 19 of plunger 12 is in communication with the secondend 8 of the hollow tube 2. This configuration permits a user to ejectsubstantially all of the bone graft material that is placed into thehollow tube 2 during a surgical procedure. One skilled in the art willappreciate that the plunger need not terminate in a generally flat,horizontal surface to affect the substantial removal of all of the bonegraft material placed into the hollow tube; more specifically, any shapethat allows conformance between the internal contour of the distal endof the hollow tube and the distal end of the plunger will affect thesubstantial removal of the bone graft material.

In the embodiment, of FIG. 1A-C, a contoured leading edge is provided onthe plunger to correspond with the internal contour of distal end of thehollow tube of the delivery device. This contoured plunger servesseveral purposes: First, it maintains the plunger in a desirablerotational position with respect to the hollow tube (i.e., prevents theplunger from inadvertently or intentionally being manipulated to rotateabout the longitudinal axis of the hollow tube). Second, it ensures thatwhen the plunger is fully inserted, the plunger removes substantiallyall of the bone graft material from the hollow tube. Also, the contouredplunger, corresponding to the contoured tubular member, allows immediateidentification of the orientation of the device, and more specificallythe direction of eject of the bone graft material into the surgicalarea. Alternative positioning means may also be provided to ensure thatthe plunger remains in the desirable position during delivery of bonegraft into the hollow tube, for example by a machined bevel or edge onthe outer surface of the plunger, and a corresponding groove in theinterior surface of the hollow tube, which must be aligned wheninserting the plunger in the hollow tube.

Referring now to FIG. 1C, an elevation view of the hollow tube 2 shownin FIG. 1A is shown in detail. The second end 8 of the hollow tube 2 hasan opening with a height A and width B according to the needs of thesurgeon, the location of the bone graft receiving area, the nature ofthe surgical operation to be performed, and the quantity and type ofbone graft that is being inserted in (and ultimately ejected from) thisintegrated fusion cage and graft delivery device. According to apreferred embodiment, the height A of the opening at the second end 8 ofthe hollow tube 2 is in the range of 4 mm to 9 mm, and in a mostpreferred embodiment is about 7 mm. According to a preferred embodiment,the width B of the opening at the second end 8 of the hollow tube 2 isin the range of 7 mm to 14 mm, and in a most preferred embodiment isabout 10 mm.

Referring to FIGS. 1A-C, it is to be understood that although theseparticular drawings reflect an embodiment where the second end 8 of thehollow tube 2, and the second end 18 of the plunger 12 comprise a curvedor sloped surface which extends at least a certain distance laterallyaway from the generally longitudinal axis of the hollow tube 2/plunger12, that in other embodiments, the second end 8 of the hollow tube 2(and thereby, the second end 18 of the plunger 12) do not extend alateral distance away, but rather terminate along the longitudinal wallof the hollow tube 2. In this embodiment, the hollow tube 2 may have asecond end 8 which has an opening that is carved out of the side of thewall of the hollow tube 2, such that it appears as a window in thetubular body of hollow tube 2. According to this embodiment, thehorizontal face 19 of the plunger 12 would also be a face on the outersurface of plunger 12, without extending any lateral distance away fromthe body of plunger 12. According to this embodiment, the plunger 12would still retain the curved or sloped surface at the opposite end ofthe horizontal face 19 (referred to in FIG. 1B as 20) and similarly thehollow tube 2 would still comprise a sloped or curved surface 10opposite the opening at second end 8. It is to be expressly understoodthat other variations which deviate from the drawing FIGS. 1A-C are alsocontemplated with the present invention, so long as that the opening atthe second end 8 of hollow tube 2 is oriented to permit bone graft to beexited from the hollow tube 2 in a generally lateral direction (inrelation to the longitudinal direction of the axis of the hollow tube2).

According to another embodiment, the plunger 12 shown in FIG. 1B mayfurther comprise a secondary handle (not shown in FIG. 1B), whichincludes an opening about at least one end of secondary handle such thatit is permitted to couple with handle 16 of plunger 12. In this fashion,the secondary handle may be larger, contain one or more rings orapertures for placing a user's hand and/or fingers, or may simply be ofa more ergonomic design, for accommodating use of the plunger 12 duringa surgical operation. The secondary handle, according to thisembodiment, is selectively removable, which permits a surgeon to use thesecondary handle for inserting the plunger 12, and then at a later pointremove the secondary handle, for instance, to improve visibility throughthe incision or through the hollow tube 2, and/or to determine whethersubstantially all of the bone graft material has been ejected from thehollow tube 2.

Referring now in detail to FIG. 2, the plunger 12 is shown inserted intothe hollow tube 2, such that the horizontal face 19 is substantiallyplanar with the opening at the second end 8 of the hollow tube 2. Asdescribed above, the geometry of plunger 12 is such that it fits snugglyor tightly in the interior of the hollow tube 2. This configuration issuch that the sloped or curved surface 10 of the hollow tube 2 issubstantially congruent to the sloped or curved surface 20 (not shown inFIG. 2), thereby allowing the plunger to be inserted into the hollowtube 2 and allowing substantially all of bone graft material which isplaced into the hollow tube 2 to be ejected by the user.

Referring now in detail to FIG. 3, an alternate embodiment of thepresent invention is shown. According to this embodiment, the hollowtube 2 comprises a footing 11 at the second end 8 of the hollow tube 2.This footing 11 extends in a lateral direction, opposite the directionof the opening at the second end 8 of the hollow tube 2. The purpose ofthis footing 11 is to prevent injury to the annulus of a patient, orother sensitive anatomy adjacent the bone graft receiving area. Thisfooting 11 is helpful when a surgeon or other user of the integratedfusion cage and graft delivery device is using the plunger 12 to drivebone graft through the hollow tube 2, or using another tool, such as atamp, mallet, or other driving or impacting device to strike the plunger12 and/or hollow tube 2 during the surgical procedure. Without thefooting 11, the hollow tube 2 would have a generally angular second end8, which may cause damage to the patient during these types ofprocedures. Thus, the footing 11 prevents the second end 8 of the hollowtube 2 from penetrating the annulus or other sensitive anatomy of thepatient.

According to this embodiment, the footing 11 may also operate to ensurea fixed position of the second end 8 of the hollow tube 2 in thesurgical site. This in turn allows a user to ensure that bone graftejecting the second end 8 of the hollow tube 2 is being ejectedlaterally, and in the desired direction. This may be important, forexample, when the integrated fusion cage and graft delivery device isplaced within a disc space, and bone graft is being ejected laterallyfrom the second end 8 of the hollow tube 2 in a specific direction. Inother embodiments, the footing 11 may also serve as a visual marker forthe surgeon, as it extends away from the horizontal wall of the hollowtube 2, and is therefore visible at the second end 8 of the hollow tube2. As shown in FIG. 3, the presence of the footing 11 does not affectthe interior slope or curved surface 10A of the hollow tube 2, so thatthe plunger 12 of the design shown in FIG. 1B may still be used with thehollow tube 2 of this alternate embodiment.

Referring now in detail to FIG. 4, a removable funnel 30 is shown, whichcomprises an opening 34 which is generally larger in diameter ordimension when compared to the opening 4 of the hollow tube 2. Thisremovable funnel 30 further comprises a sleeve 32, the sleeve 32 havingan internal cross-section which is substantially congruent with theexternal cross-section of the first end 6 of the hollow tube 2. Thus,according to this embodiment, the funnel 30 is selectively removablefrom the first end 6 of the hollow tube 2, and may allow a surgeon tomore easily place new or additional bone graft into the hollow tube 2 byway of the opening 34 of the funnel 30. This funnel 30 may be used inconnection with a hollow tube 2 that has been pre-filled with bonegraft, or a hollow tube which is not pre-filled with bone graft. Thus,the funnel may be selectively positioned on the first end 6 of thehollow tube 2 at any point during the surgical operation when thesurgeon desires new or additional bone graft be placed in the hollowtube 2 of the integrated fusion cage and graft delivery device.

Referring now in detail to FIG. 5, one particular application of theintegrated fusion cage and graft delivery device is shown in aperspective view. Here, the integrated fusion cage and graft deliverydevice is shown with the embodiment of the hollow tube 2 furthercomprising a footing 11, and a second end opening for ejecting bonegraft in a generally lateral direction, here in the interior of a discspace 40. The disc is shown with an opening on one end for inserting thesecond end 8 of the hollow tube 2 of the integrated fusion cage andgraft delivery device. As opposed to prior art integrated fusion cageand graft delivery devices which have an opening at a second end that isopen to the longitudinal axis of the delivery device, the presentinvention comprises a lateral opening, which as shown in FIG. 5 allows asurgeon to eject bone mill into the lateral direction and thereby intothe opened areas of the disc space 40. A surgeon has the option torotate the direction of the opening in the second end 8 of the hollowtube 2 for ejecting additional bone graft to other open areas in thedisc space 40. Once the disc space 40 is substantially full of bonegraft, the surgeon may remove the hollow tube 2 without disturbing thedisc or anatomy of the patient. The surgeon may also accomplish thedelivery of bone graft without displacing any cage or other structuralimplantable device which may be present in or adjacent the disc space.One skilled in the art will appreciate that the hollow tube 2 furthercomprising a footing 11, and a second end opening for ejecting bonegraft in a generally lateral direction, may affect the delivery of bonegraft in a lateral direction simultaneous with delivery in alongitudinal direction.

Referring now to FIGS. 6-10D, a preferred embodiment of the device isshown. In regard to FIG. 6, an integrated fusion cage and graft deliverydevice portion is shown, comprised of a hollow tubular member 2, whichhas a first proximate end 6 and a second distal end 8, with a generalhollow structure therebetween. The generally hollow tube 2 is shown withone of two lateral openings at the distal end 8 of the tubular member 2viewable (the other is viewable in FIG. 7). Also in FIG. 6, the plungermember 12 is shown. The manner of insertion of plunger member 12 intotubular member 2 is also provided. Thus, as shown in FIG. 6, the hollowtube 2 allows bone graft material to be inserted into the opening 4 atthe proximal end 6 of the hollow tube 2, and ultimately exited from thehollow tube 2 through the second distal end 8 from the lateral openingsat the distal end 8 of the hollow tubular member 2.

Furthermore, regarding FIG. 6, a preferred embodiment of the distal end8 of the tubular member 2 and the distal end 18 of the plunger member 12is provided. The configuration provided, a wedge-shaped end 50 of thetubular member 2 and a wedge-shaped end 52 of the plunger 12, allowssubstantially all of the bone graft material to be removed and thusinserted into the surgical area when the plunger 12 is fully insertedinto the tubular member 2. The wedge-shaped feature 50 of the distal end8 of the tubular member 2 and the wedge-shaped end 52 of the distal end18 of the plunger member 12 is discussed in additional detail withrespect to FIGS. 8 and 9 below. The ability to remove substantially allof the bone graft material is an important feature of the inventionbecause bone graft material is traditionally expensive and may requiresurgery to obtain.

Referring now to FIG. 7, a perspective view of a preferred embodiment ofthe hollow tubular member 2 is provided. Consistent with FIG. 6, thegenerally hollow tube 2 is shown with one of two lateral openings at thedistal end 8 of the tubular member 2 viewable (the other is viewable inFIG. 6). Thus, in operation the hollow tube 2 allows bone graft materialto be inserted into the opening 4 at the proximal end 6 of the hollowtube 2, and ultimately exited from the hollow tube 2 through the seconddistal end 8 from the lateral openings at the distal end 8 of the hollowtubular member 2. In this configuration, bone graft material is ejectedinto the surgical area in two lateral directions. One skilled in the artwill appreciate that the openings at the distal end 8 of the hollowtubular member 2 need not be positioned exclusively on one or morelateral sides of the distal end 8 of the tubular member to allow bonegraft material to be provided to the surgical site in other than apurely axial or longitudinal direction. Further, one skilled in the artwill appreciate that the specific absolute and relative geometries andnumbers of lateral openings may vary, for example the distal end 8 ofthe tubular member 2 may have more than two openings that are ofdifferent shape (e.g. oval, rectangular), and/or one or more lateralopenings may comprise a first pair of edges and a second pair of edges,wherein the first pair of edges are straight and the second pair ofedges are not straight.

Referring now to FIG. 8, an elevation view of the wedge-shaped distalend 50 of the tubular member 2 is provided. In this embodiment, thedistal end 52 of the plunger 12 would conform to the same shape, toallow close fitting of the plunger and the hollow tubular member.

This contoured plunger, corresponding to the contoured tubular member,serves several purposes: First, it maintains the plunger in a desirablerotational position with respect to the hollow tube (i.e., prevent theplunger from inadvertently or intentionally being manipulated to rotateabout the longitudinal axis of the hollow tube); Second, it ensures thatwhen the plunger is fully inserted, the plunger removes substantiallyall of the bone graft material from the hollow tube. Also, the contouredplunger, corresponding to the contoured tubular member, allows immediateidentification of the orientation of the device, and more specificallythe direction of eject of the bone graft material into the surgicalarea. One skilled in the art will appreciate that the plunger 12 neednot terminate in a wedge-shape surface 52 to affect the substantialremoval of all of the bone graft material placed into the hollow tube 2;more specifically, any shape that allows conformance between theinternal contour of the distal end of the hollow tube and the distal endof the plunger will affect the substantial removal of the bone graftmaterial.

Referring now to FIG. 9, an elevation view of the opening 4 of theproximal end 6 of the hollow tubular member 2 is provided. As shown inFIG. 9, the opening 4 at the proximal end 6 of the hollow tube 2 allowsdeposit of bone graft material. In this configuration, the cross-sectionof the opening 4 at the proximal end 6 of the hollow tube 2 is generallysquare. Although a generally square cross-section is depicted, thecross-section need not be limited to a generally square shape. Forexample, cross-sections of an oval shape or those with at least onedefined angle to include obtuse, acute, and right angles can provide ashape in some situations that is more congruent with the size or shapeof the annulotomy of a particular disc space.

Referring to FIGS. 10A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting the complete insertion of theplunger 12 into the hollow tubular member 2. In each of FIGS. 10A-D, thewedge-shaped distal end 50 of the tubular member 2 is depicted. Also,each of FIGS. 10A-D depict the additional length of the plunger element12 when inserted into the tubular member 2. FIG. 10A shows one of twolateral openings at the distal end 8 of the hollow tubular member 2.FIG. 10C shows another of the two lateral openings at the distal end 8of the hollow tubular member 2. One skilled in the art will appreciatethat the openings at the distal end 8 of the hollow tubular member 2need not be positioned exclusively on one or more lateral sides of thedistal end 8 of the tubular member to allow bone graft material to beprovided to the surgical site in other than a purely axial orlongitudinal direction. Further, one skilled in the art will appreciatethat the specific absolute and relative geometries and numbers oflateral openings may vary, for example the distal end 8 of the tubularmember 2 may have more than two openings that are of different shape(e.g. oval, rectangular).

Referring to FIGS. 11A-D, a fusion cage 60 of an integrated fusion cageand graft delivery device 1 portion is shown, which is comprised of anintegrated fusion cage 60 that comprises a first proximal end 62 and asecond distal end 64 wherein the first proximal end contains an opening66 adapted to allow fitting and/or engagement to the distal end 8 of thehollow tube 2. This fitting and/or engagement may be over the externalsurface of the hollow tube 2 or inside the interior of the hollow tube2. Further, the integrated fusion cage 60 may comprise one or moremedial openings 68 that align with one or more openings at the distalend 8 of the hollow tube 2. Further, the integrated fusion cage 60 maycontain non-smooth surfaces, such as belts or striations, along one ormore medial surfaces 70 of the integrated fusion cage 60. The integratedfusion cage 60 is configured such that when a plunger 12, once fullyinserted into the hollow tube 2, is substantially congruent with thehollow interior portion of the hollow tube 2, e.g. both the plunger 12and the hollow tube 2 are substantially the same shape and/or class andbone graft material is delivered through the integrated fusion cage 60into the surgical area.

In a preferred embodiment, the fusion cage 60 has a tapered tip, andseveral open channels along the medial and lateral surfaces. In apreferred embodiment, the fusion cage 60 and/or the bone graft deliveryportion of the integrated fusion cage and graft delivery device is ofoblong or rectangular or square shape. The integrated fusion cage andgraft delivery device 1 is designed to avoid blocking or impacting bonegraft material into a surgical disc space, thereby limiting the bonegraft material that may be delivered, and not allowing available fusionspace to be fully exploited for fusion.

In a preferred embodiment, the fusion cage 60 has a keel-shaped tip toseparate disk and prevent annular penetration. Also, the fusion cage 60may have dual portals for bone graft discharge, with the medial openings68 larger than the lateral openings 69. Further, the fusion cage may bedesigned in variable heights and lengths so that it fits snugly into theprepared disk space.

Referring now to FIGS. 12A-C, two alternate embodiments of the fusioncage 60 are provided. FIG. 12A shows an embodiment of the integratedfusion cage 60 with a second distal end 64 tapered to a flat rectangularshape end. FIG. 12B shows an embodiment of the integrated fusion cage 60with a second distal end 64 tapered to a wedged-shaped end. Such aconfiguration would be, for example, would be conformal with thewedge-shaped second end 50 of the hollow tube 2, as shown in FIGS. 6-8.FIG. 12C shows an embodiment of the integrated fusion cage 60 with beltsof striations imparted to the upper medial surface 70 of the fusion cage60.

In regard to FIG. 13, an integrated fusion cage and graft deliverydevice 1 is shown, comprised of a hollow tubular member 2, which has afirst proximate end 6 and a second distal end 8, with a general hollowstructure therebetween. The generally hollow tube 2 is shown with one oftwo lateral openings at the distal end 8 of the tubular member 2viewable. Also in FIG. 13, the plunger member 12 is shown and the fusioncage 60. The manner of insertion of plunger member 12 into tubularmember 2 is also provided, as is the manner of insertion of fusion cage60 over tubular member 2 and into the fusion cage first end opening 66.Thus, as shown in FIG. 13, the hollow tube 2 allows bone graft materialto be inserted into the opening 4 at the proximal end 6 of the hollowtube 2, and ultimately exited from the hollow tube 2 through the seconddistal end 8 from the lateral openings at the distal end 8 of the hollowtubular member 2 and through the medial openings 68 and/or the lateralopenings 69 of the fusion cage 60. In one embodiment as shown in FIG.13, the lateral openings at the distal end 8 of the hollow tubularmember 2 are preferably disposed within a distance from the distal end 8not exceeding 25% of the total distance (or length) of the hollow tubemember 2, more preferably not exceeding 15% of this identified distance,and most preferably not exceeding 10% of this identified distance. Inone embodiment as shown in FIG. 13, the lateral openings at the distalend 8 of the hollow tubular member 2 are preferably disposed within adistance from the distal end 8 not exceeding 10 cm of the total distance(or length) of the hollow tube member 2, more preferably not exceeding 8cm of this identified distance, and most preferably not exceeding 5 cmof this identified distance.

Referring to FIGS. 14A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting sequential elevation views ofthe integrated fusion cage and graft delivery device 1 with the plungerportion 12 fully inserted into the tubular portion 2 and the fusion cage60 fully inserted over the tubular portion 2. One skilled in the artwill appreciate that the openings at the distal end 8 of the hollowtubular member 2 need not be positioned exclusively on one or morelateral sides of the distal end 8 of the tubular member to allow bonegraft material to be provided to the surgical site in other than apurely axial or longitudinal direction. Further, one skilled in the artwill appreciate that the specific absolute and relative geometries andnumbers of lateral and medial openings may vary, for example the distalend 8 of the tubular member 2 may have more than two openings that areof different shape (e.g. oval, rectangular).

Referring to FIGS. 15A-D, a fusion cage 60 of an integrated fusion cageand graft delivery device portion is shown, which is comprised of anintegrated fusion cage 60 that comprises a first proximal end 62 and asecond distal end 64 wherein the first proximal end contains an opening66 adapted to allow fitting and/or engagement to the distal end 8 of thehollow tube 2. This fitting and/or engagement may be over the externalsurface of the hollow tube 2 or inside the interior of the hollow tube2. Further, the integrated fusion cage 60 may contain non-smoothsurfaces, such as belts or striations, along one or more medial surfaces70 of the integrated fusion cage 60. The integrated fusion cage 60 isconfigured such that when a plunger 12, once fully inserted into thehollow tube 2, is substantially congruent with the hollow interiorportion of the hollow tube 2, e.g. both the plunger 12 and the hollowtube 2 are substantially the same shape and/or class and bone graftmaterial is delivered through the integrated fusion cage 60 into thesurgical area.

In a preferred embodiment, the fusion cage 60 has a tapered tip, andseveral open channels along the medial and lateral surfaces. In apreferred embodiment, the fusion cage 60 is of a square shape and thebone graft delivery portion of the integrated fusion cage and graftdelivery device is of a cylindrical shape. The integrated fusion cageand graft delivery device 1 is designed to avoid blocking or impactingbone graft material into a surgical disc space, thereby limiting thebone graft material that may be delivered, and not allowing availablefusion space to be fully exploited for fusion.

In a preferred embodiment, the fusion cage 60 has a keel-shaped tip toseparate disk and prevent annular penetration and has internal ramps 72which assist in directing the bone graft material to one or more lateralopenings 69. As the plunger 12 is inserted into the hollow tube 2, bonegraft material is directed by the fusion cage internal ramps 72 out thelateral openings 69, and bone additionally bone graft material may flowout the one or more medial openings 68. The plunger end 18 may beconfigured to be conformal with the internal ramps 72 of the fusion cage60, as depicted in FIG. 15B. Also, the fusion cage 60 may have dualportals for bone graft discharge, with the medial openings 68 largerthan the lateral openings 69. Further, the fusion cage may be designedin variable heights and lengths so that it fits snugly into the prepareddisk space.

In a preferred embodiment as shown in FIGS. 15B-D, the hollow tube 2 isof cylindrical shape and includes one or more locking tabs 80 configuredto engage one or more locking slots 82 of the fusion cage 60. Thelocking tabs 80 may permanently or not permanently engage the lockingslots 82, and may be of shape to include rectangular, circular andoblong. The instruments used with the integrated fusion cage and graftdelivery device described above in its varying embodiments may includeone or more tamps, preferably having a configuration which at least inpart corresponds in shape and contour of the hollow tube portion of thedelivery device. The one or more tamps may be adapted to correspondfurther to the shape and contour of the graspable end of the plunger,for use in driving the plunger through the hollow tube portion of thedelivery device to ensure any remaining bone graft located in the hollowtube is delivered to the graft receiving area.

In the embodiment of the device of FIG. 16, the hollow tube 2 engageswith the fusion cage 60 via a break-off collar 90 and the plunger 12inserts into the interior of the hollow tube 2. The plunger 12 isdepicted partially inserted into the hollow tube 2. The break-off collar90 may be severed by any of several means, to include application oftorsion and/or rotational force and/or lateral force to break-off collar90, for example by twisting on the hollow tube 2 and/or the plunger 12.

In the embodiment of the device of FIG. 17A-B, the hollow tube 2 engageswith a connector conduit 100 which in turn connects with the fusion cage60 via a break-off collar 90. One or more connectors 102 connect thehollow tube 2 with the connector conduit 100. The hollow tube 2 fitsover the connector conduit 100. The one or more connectors 102 fitthrough the hollow tube 2 and the connector conduit 100. The break-offcollar 90 may be severed by any of several means, to include applicationof torsion and/or rotational force and/or lateral force to break-offcollar 90, for example by twisting on the hollow tube 2 and/or theplunger 12. In one embodiment of the connector conduit 100, as shown inFIG. 17B, the connector conduit 100 is of circular cross-section.

Referring to FIGS. 18A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting sequential elevation views ofthe integrated fusion cage and graft delivery device 1 with telescopingtubular portion 2 and the fusion cage 60 fully inserted over the tubularportion 2. One skilled in the art will appreciate that the openings atthe distal end 8 of the hollow tubular member 2 need not be positionedexclusively on one or more lateral sides of the distal end of thetubular member to allow bone graft material to be provided to thesurgical site in other than a purely axial or longitudinal direction.

In an embodiment of the invention particularly suited for ALIFprocedures, a fusion cage 110 as shown in FIGS. 19A-D comprises a hollowinternal chamber 114 in fluid communication with bone graft dischargeportals 112 and a charging portal 116, which comprises a break-offcollar in some embodiments such as those depicted in FIGS. 17A-D. Thefusion cage 110 has a substantially cylindrical shape, with thedischarge portals 112 located opposite each other on the curved lateralportion of the fusion cage 110 and the charging portal 116 locatedsubstantially in between the discharge portals 112 on the curvedanterior portion of the fusion cage 110. The curved posterior portion ofthe fusion cage 110 is substantially devoid of portals from the internalchamber 114 to the exterior of the fusion cage 110. The charging portal116 is adapted to receive a hollow tube such as the hollow tube 2 shownin other embodiments described herein. Bone graft material enters theinternal chamber 114 through a hollow tube connected to the chargingportal 116, and exits the internal chamber 114 through the dischargeportals 112. The discharge portals 112 are positioned so that when thefusion cage 110 is properly positioned in between two vertebrae, bonegraft material discharged therethrough fills the space in between thevertebrae on the lateral sides of the spine, but does not discharge intoor fill the anterior or posterior space in between the vertebrae. Inembodiments of fusion cage 110 comprising a break-off collar, once thefusion cage 110 is properly positioned and the desired amount of bonegraft material has been inserted into the chamber 114 and dischargedthrough the discharge portals 112, the break-off collar is severed fromthe fusion cage 110 (as described with respect to other embodimentsherein) and removed from the patient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 116 of fusion cage 110 is adapted to removably receive a hollowtube (such as the hollow tube 2 shown in other embodiments describedherein). For example, the walls of the charging portal 116 may bethreaded so that the hollow tube can be screwed into the charging portal116.

The fusion cage 110 preferably has a height of from about 8 millimetersto about 14 millimeters, and a diameter of less than about 36millimeters. The fusion cage 110 is made from polyether ether ketone(PEEK), titanium, a composite material, or any other material suitablefor implantation in a human body. The fusion cage 110 comprises, in someembodiments, ramps within internal chamber 114 to guide bone graftmaterial to discharge portals 112.

In an embodiment of the invention particularly suited for D-LIFprocedures, a fusion cage 120 as shown in FIGS. 20A-D comprises a hollowinternal chamber 124 in fluid communication with bone graft dischargeportals 122 and a charging portal 126, which in someembodiments—including the embodiment shown in FIGS. 20A-D—comprises abreak-off collar. The fusion cage 120 is substantially shaped as arectangular prism, with the discharge portals 122 located on oppositesides of the fusion cage 120 and the charging portal 126 located on alateral face of the fusion cage 120. The opposite lateral face of thefusion cage 120 is devoid of portals from the internal chamber 124 tothe exterior of the fusion cage 120. The charging portal 126 is adaptedto receive a hollow tube such as the hollow tube 2 shown in otherembodiments described herein. Bone graft material enters the chamber 124through a hollow tube connected to the charging portal 126, and exitsthe internal chamber 124 through the discharge portals 122. Thedischarge portals 122 are positioned so that when the fusion cage 120 isproperly positioned in between two vertebrae, bone graft materialdischarged therethrough fills the space in between the vertebrae towardsthe anterior and posterior of the spine, but does not discharge into orfill the lateral space in between the vertebrae. As with otherembodiments described herein, in embodiments that comprise a break-offcollar, once the fusion cage 120 is properly positioned and the desiredamount of bone graft material has been inserted into the chamber 124through charging portal 126 and discharged through the discharge portals122, the break-off collar is severed from the fusion cage 120 (asdescribed with respect to other embodiments herein) and removed from thepatient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 126 is adapted to removably receive a hollow tube (such as thehollow tube 2 shown in other embodiments described herein). For example,the internal walls of charging portal 126 may be threaded so that thehollow tube can be screwed into the charging portal 126.

The fusion cage 120 preferably has a height of from about 8 millimetersto about 14 millimeters, and a length of from about 22 millimeters toabout 36 millimeters. The fusion cage 120 is made from polyether etherketone (PEEK), titanium, a composite material, or any other materialsuitable for implantation in a human body. The fusion cage 120comprises, in some embodiments, ramps within internal chamber 124 toguide bone graft material to discharge portals 122.

Referring now to FIGS. 21A-D, in embodiments of the inventionparticularly suited for use in connection with a vertebrectomy, a fusioncage 130 comprises a substantially cylindrical wall surrounding aninternal chamber 134. Thus, the fusion cage 130 has a substantiallycylindrical shape. Internal chamber 134 is open at the top and thebottom of fusion cage 130, and lateral portions 132 of the cylindricalwall of the fusion cage 130 are porous to bone graft material (i.e. bonegraft slurry). Anterior and posterior portions 138 of the cylindricalwall of fusion cage 130 in between porous portions 132 are impervious tobone graft material. A charging portal 136—which in some embodiments,including the embodiment shown in FIGS. 21A-D, comprises a break-offcollar—is positioned on an impervious portion 138 of fusion cage 130.The charging portal 136 is adapted to receive a hollow tube such as thehollow tube 2 shown in other embodiments described herein. Bone graftmaterial enters the chamber 134 through a hollow tube connected to thecharging portal 136, and exits the chamber 134 through porous wallportions 132. The porous wall portions 132 are positioned so that whenthe fusion cage 130 is properly positioned in between two vertebrae,bone graft material discharged therethrough fills the space in betweenthe vertebrae on either side of the spine, but the impervious wallportions 138 prevent bone graft material from discharging into theanterior or posterior space in between the vertebrae, thus preventingbone graft material from pushing against the spinal cord. In embodimentsof fusion cage 130 comprising a break-off collar, once the fusion cage130 is properly positioned and the desired amount of bone graft materialhas been inserted into the chamber 134 through charging portal 136 anddischarged through the porous wall portions 132, the break-off collar136 is severed from the fusion cage 130 (as described with respect toother embodiments herein) and removed from the patient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 136 is adapted to removably receive a hollow tube (such as thehollow tube 2 shown in other embodiments described herein). For example,the internal walls of the charging portal 136 may be threaded so thatthe hollow tube can be screwed into the charging portal 136.

The fusion cage 130 preferably has a height equal to or greater than thevertebra or vertebrae it is intended to replace, and a diameter of lessthan about 36 millimeters. The fusion cage 130 is made of polyetherether ketone, titanium, a composite material, or any other materialsuitable for implantation in a human body. In some embodiments, ramps inthe internal chamber 134 guide the bone graft material to the porouslateral faces 132.

Referring now to FIGS. 22-33, another embodiment of the device fordelivering bone graft is provided. In regard to FIGS. 22-28, integratedfusion cage and graft delivery device 1 is shown. FIG. 22 is aperspective view of the device 1, FIG. 23 a perspective exploded view,FIG. 24 a top plan view, FIG. 25 a front elevation view, FIG. 26 a rightelevation view, FIG. 27 is a bottom plan view, and FIG. 28 is across-sectional view of section A-A of FIG. 25.

Device 1 is comprised of a hollow tubular member or hollow tube 2, aplunger 12 which fits within the hollow tube 2, and a funnel 30. Thefunnel 30 engages the upper or distal or first end 6 of the hollow tube,and comprises a sleeve 32 and opening 34. Medical material, such as bonegraft material, is inserted into opening 34 of funnel 30, which in turnenters hollow tube 2. Hollow tube 2 comprises hollow tube first exteriorsurface 3, hollow tube second exterior surface 5, first end 6, secondend 8, and hollow tube first distal opening 7. Hollow tube 2 isgenerally of symmetrical shape such that first exterior surface 3comprises two such surfaces opposite or at 180 degrees from one another,and second exterior surface 5 comprises two such surfaces opposite or at180 degrees from one another. Also, hollow tube first distal opening 7is positioned on each of two opposite sides of hollow tube 2 at secondend 8, each opening from hollow tube first exterior surface 3.

Funnel 30 is configured with sleeve 32 such that funnel 30 may bepositioned at second end 8 of hollow tube 2 such that hollow tube mayfit through funnel 30, enabling funnel 30 to move along hollow tube 2from second end 8 of hollow tube 2 to first end 6 of hollow tube 2 untilfunnel 30 engages first end 6 of hollow tube, such as at protrusion orshelf depicted in FIG. 23.

Plunger 12 comprises handle 16 at upper or proximal end of plunger 12,plunger distal or second end 18. Plunger second end 18 comprises distalfirst surface 13, distal second surface 14 and distal third (or bottom)surface 15. Plunger second end 18 is generally of symmetrical shape suchthat distal first surface 13 comprises two such surfaces opposite or at180 degrees from one another, and distal third surface 15 comprises twosuch surfaces opposite or at 180 degrees from one another. Plunger 12 isconfigured such that second end 18 forms a congruent or conformalengagement with the interior of the hollow tube 2. Stated another way,the plunger second end 18 fits within the hollow tube 2 so as to slidewithin the hollow tube with minimal to no effective spacing between theexterior surface of the plunger second end 18 and the interior of thehollow tube 2, thereby forcing through bone graft material positioned inthe hollow tube 2 through the hollow tube when the plunger 12 (and thusits second end 18) is axially moved from hollow tube first end 6 tohollow tube second end 8.

In regard to FIGS. 29-31, further features of the plunger 12 aredescribed. FIG. 29 is a front elevation view of the plunger element ofthe device shown in FIG. 22, FIG. 30 is a cross-sectional view ofsection B-B of FIG. 29, and FIG. 31 is a cross-sectional of section C-Cof FIG. 29. Plunger 12 comprises handle 16 at upper or proximal end ofplunger 12, plunger distal or second end 18. Plunger second end 18comprises distal first surface 13, distal second surface 14 and distalthird (or bottom) surface 15. Plunger medial portion 17 forms a crossconfiguration, as depicted in FIG. 30, such that distal first surfaces13 are of reduced width relative to width at second end 18. Similarly,plunger distal second surfaces 14, at plunger medial portion 17, are ofreduced width relative to width at second end 18. At distal end 18 ofplunger 12, plunger cross-section is a rectangle, as depicted in FIG.31.

In regard to FIGS. 32 and 33, additional detail of the distal portion ofdevice 1 are provided. FIG. 32 is a detailed view of a portion of thedevice 1 shown in FIG. 22 and FIG. 33 is a cross-sectional view ofsection D-D of FIG. 32. Each of FIGS. 32 and 33 depict the device 1 whenthe plunger 12 is fully inserted into the hollow tube 2, and the plungerdistal third surface 15 has engaged and is in contact with the hollowtube distal interior ramp 9. Hollow tube distal interior ramp 9comprises hollow tube distal interior ramp surfaces 9A, symmetricallypositioned about the middle of the hollow tube second end 8. Hollow tubedistal interior ramp surfaces 9A are of curvilinear shape forming aterminus, and urge bone graft material, when disposed within the hollowtube 2, to substantially exit the pair of first distal openings 7 of thedevice 1.

Referring now to FIGS. 36-39 another embodiment of an integrated fusioncage and graft delivery device 1 is provided. With reference to FIGS.36-39, the integrated fusion cage and graft delivery device 1 comprisesplunger 12, hollow tube 2, fusion cage 60 and ejection tool 140. Thefusion cage 60 comprises fusion cage second or distal end 64 withtapered end feature and fusion cage first or proximal end 62 comprisingfusion cage collar 92, fusion cage collar face 93 and fusion cage collarcavity 94. Hollow tube 2 comprises hollow tube second end 8 whichengages fusion cage collar 92 by fitting over fusion cage collar 92 in apress or interference fit. Plunger 12 fits within hollow tube 12, andfurther may optionally fit within fusion cage collar cavity 94 so as toenter into interior of fusion cage 60 as previously described above.

Ejection tool 140 comprises ejection tool second or distal end 152 andejection tool first or proximal end 142. Ejection tool second end 152engages fusion cage collar face 93 to apply force or push fusion cage 60from engagement with hollow tube 2. Ejection tool second end 152 isconfigured such that it may not travel past or into the fusion cage.When sufficient axial force is applied to the ejection tool 140 in thedirection of the fusion cage 60, the interference fit that secures thefusion cage 60 (at fusion cage collar 92) to hollow tube 2 (at secondend 8 of hollow tube) is overcome and the fusion cage 60 is released ordisengaged from the hollow tube 2. Ejection tool 140 further comprisesan ejection tool L-cut 151 that engages knobs 6A of hollow tube 2. Inone embodiment, knobs 6A of hollow tube 2 are configured to additionallyor alternatively engage L-cuts of the funnel 30 at funnel sleeve 32 (SeeFIG. 23). Plunger 16 further comprises handle 16 and plunger stop 16Awhich engages upper portion of hollow tube 2. Plunger stop 16A may beconfigured to prevent plunger distal most portion from entering fusioncage collar cavity 94 and therefore further prevent entry into interiorof fusion cage 60.

Fusion cage 60 further comprises fusion cage internal ramps 72 asdescribed above. The fusion cage internal ramps 72 may be symmetricalabout a centerline of the device 1, and may be linear or slopedinwardly. In one embodiment, plunger stop 16A may be configured toprevent plunger distal most portion from striking or contacting fusioncage internal ramps 72 but otherwise allowing entry into fusion cagecollar cavity 94 and therefore also allow entry into interior of fusioncage 60.

Fusion cage 60 further comprises fusion cage first opening or port pair65 and fusion cage second opening or port pair 67. Fusion cage firstopening pair 65 are symmetric about a vertical plane intersecting acenterline of the fusion cage 60, and are located such that at least aportion of the openings are adjacent the tip of the fusion cage internalramps 72. The fusion cage first opening pair 65 are of an oblongracetrack shape, but in other embodiments may be oval, circular andrectangular. The fusion cage second opening pair 67 are of an ovalshape, but in other embodiments may be oblong racetrack, circular andrectangular. The fusion cage may have rounded or no square edges, andmay have a non-smooth exterior surface or any or all portions. That is,the fusion cage 60 may have ridges, bumps, contours, sawtooth profileedges along or on top of any or all exterior surfaces, such as surfacesadjacent the fusion cage second opening pair 67 and/or fusion cage firstopening pair 65.

Referring now to FIGS. 40-41, another embodiment of an integrated fusioncage and graft delivery device 1 is provided. FIG. 40 is a frontperspective view of an integrated fusion cage and graft delivery device1, and FIG. 41 is a closed-up front perspective view of a portion of thedevice of FIG. 40. The embodiment of FIGS. 40-41 comprises a pair offusion cage tab extensions 96, each of which comprises a fusion cage tabextension latch 97. Integrated fusion cage and graft delivery device 1comprises plunger 12, hollow tube 2 and fusion cage 60. FIG. 40 depictsthe integrated fusion cage and graft delivery device 1 with plunger 12fully inserted into hollow tube 2 such that plunger stop 16A engagesupper portion of hollow tube 2. The fusion cage 60 comprises fusion cagesecond or distal end 64 with tapered end feature and fusion cage firstor proximal end 62 comprising fusion cage collar 92, fusion cage collarface 93 and fusion cage collar cavity 94.

Fusion cage 60 further comprises fusion cage internal ramps 72 asdescribed above. The fusion cage internal ramps 72 may be symmetricalabout a centerline of the device 1, and may be linear or slopedinwardly. Fusion cage 60 further comprises fusion cage first opening orport pair 65 and fusion cage second opening or port pair 67. Fusion cagefirst opening pair 65 are symmetric about a vertical plane intersectinga centerline of the fusion cage 60, and are located such that at least aportion of the openings are adjacent the tip of the fusion cage internalramps 72. The fusion cage first opening pair 65 are of an oblongracetrack shape, but in other embodiments may be oval, circular andrectangular. The fusion cage second opening pair 67 are of an ovalshape, but in other embodiments may be oblong racetrack, circular andrectangular. The fusion cage may have rounded or no square edges. Fusioncage 60 has fusion cage surface texture 61, depicted as a series oflateral sawtooth-like ridges.

Fusion cage tab extensions 96, each of which comprises a fusion cage tabextension latch 97, function, among other things, to increase stabilityof the interface or connection between the distal end of the hollow tube2 and the fusion cage 60. The fusion cage tab extension latches 97 maybe configured to engage corresponding grooves on the interior surface ofthe hollow tube 2. The fusion cage tab extensions 96 fit inside the endof the hollow tube and, in one embodiment, provide a force directedoutwards to or against the interior of the hollow tube. The verticalheight and longitudinal (axial) length of the fusion cage tab extensions96 provide more secure fit between the hollow tube 2 and the fusion cage60 by restricting rotational movement, for example, of the hollow tube 2with respect to the fusion cage 60. After bone graft material isprovided to the fusion cage 60 by way of the plunger 12 (as describedabove), the fusion cage tab extensions 96 may be broken-off byapplication of a tool, such as the ejection tool 140, engaged with thefusion cage tab extension latches 97 so as to fatigue or otherwisesevere the fusion cage tab extensions 96.

Referring now to FIGS. 42-43, another embodiment of the ejection tool140 of an integrated fusion cage and graft delivery device 1 isprovided. FIG. 42 is a close-up front perspective view of the ejectiontool first end 142, and FIG. 43 is a cut-away cross-sectional view ofFIG. 42. Ejection tool 140 comprises ejection tool cover 144 whichengages ejection tool wings 149. Ejection tool 140 engages with hollowtube 2 at hollow tube knobs 6A via ejection tool L-cuts 151. Ejectiontool cover 144 comprises cylindrically-shaped ejection tool cover cavity145 which fits over cylindrically-shaped ejection tool wings cavity 150and over spring cover 146. Spring cover is secured to ejection toolcover 144 by spring cover attachment 147, which may be a pin, a screw orother means known in the art, and further fits around at least a portionof coiled spring 148. When ejection tool cover 144 is pushed downwardtoward fusion cage 60, the spring 148 compresses and imparts a force inthe opposite direction, thereby returning the ejection tool cover 144 toits original (retracted) position. In use, after securing the ejectiontool first end 142 to hollow tube 2 as described above, the user (e.g.surgeon) squeezes the injection tool cover 144 against the ejection toolwings 149, thereby advancing the ejection tool rod 160 downwards insidethe hollow tube so as to engage the fusion cage 60 at the fusion cagecollar face 93 and release or disengage the fusion cage 60 from thehollow tube 2. The injection tool 140 and hollow tube 2 may then beremoved from the surgical site (e.g. spinal disk space) as one unit,leaving the fusion cage in the surgical site.

FIG. 44 is a close-up cut-away cross-sectional view of one embodiment ofthe integrated fusion cage and graft delivery device 1. FIG. 44 depictsa configuration of the integrated fusion cage and graft delivery device1 wherein the plunger 12 is configured to traverse the length of thehollow tube 2, past the fusion cage collar 92 and into the fusion cage60, stopping just prior to engaging the tip of the fusion cage internalramps 72. Fusion cage 60 is depicted with fusion cage first opening pair65 and fusion cage second end 64.

FIGS. 45-48 are scaled drawings of, respectively, the fusion cage 60,the hollow tube 2, the plunger 12 and the ejection tool 140 of yetanother embodiment of the integrated fusion cage and graft deliverydevice 1, and operate in coordination with one another.

FIGS. 45A-G provide scaled views of one embodiment of the fusion cageelement of yet another embodiment of the integrated fusion cage andgraft delivery device configured to operate with the hollow tube ofFIGS. 46A-H, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E.Fusion cage 60 comprises fusion cage second or distal end 64 withtapered end feature and fusion cage first or proximal end 62 comprisingfusion cage collar 92, fusion cage collar face 93 and fusion cage collarcavity 94. Fusion cage 60 further comprises fusion cage first opening orport pair 65, fusion cage second opening or port pair 67, fusion cagesurface texture 61 and fusion cage internal ramps 72.

FIGS. 46A-H provide scaled views of one embodiment of the hollow tube(aka snap on cannula) of the integrated fusion cage and graft deliverydevice configured to operate with the fusion cage element of FIGS.45A-G, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E. Hollowtube 2 comprises first end 6 with knobs 6A and second end 8 comprisinghollow tube cage clamp 8A and hollow tube cage clamp radial surface 8B.Hollow tube cage clamp radial surface 8B is configured to engage fusioncage collar 92, for example by an interference or friction fit (i.e. to“snap-on”). Other means of connection comprise those known to thoseskilled in the art, such as a threaded-screw engagement and a tongue andgroove engagement.

FIGS. 47A-D provide scaled views of one embodiment of the plunger (akasnap on plunger) of the integrated fusion cage and graft delivery deviceconfigured to operate with the fusion cage element of FIGS. 45A-G,hollow tube of FIGS. 46A-H, and ejection tool of FIGS. 48A-E. Plunger 12comprises handle 16, plunger stop 16A, plunger medial portion 17 andsecond end 18. Second end 18 may be configured to pass into and/orthrough fusion cage collar cavity 94.

FIGS. 48A-E provide scaled views of one embodiment of the ejection tool(aka cage insertion tool) of the integrated fusion cage and graftdelivery device configured to operate with the fusion cage element ofFIGS. 45A-G, hollow tube of FIGS. 46A-H and plunger of FIGS. 47A-D.Ejection tool 140 comprises ejection tool second or distal end 152,ejection tool first or proximal end 142 and ejection tool stop 143.Ejection tool second end 152 engages fusion cage collar face 93 to applyforce or push fusion cage 60 from engagement with hollow tube 2.Ejection tool second end 152 is configured such that it may not travelpast or into the fusion cage.

A method of use of the integrated fusion cage and graft delivery device1 as depicted in any of the afore-mentioned embodiments of FIGS. 37-48would be performed as follows. The fusion cage 60 is attached to thehollow tube 2 by way of the above-discussed interference fit at fusioncage collar 92 and interior surface of distal end of hollow tube 2.Funnel 30 is then attached to upper portion of hollow tube at first orupper or proximal end of hollow tube 2 via knobs 6A. Bone graft or othersuitable substance as known to one skilled in the art is inserted atupper or first end 6 of hollow tube 2. Plunger 12 is then inserted intohollow tube 2 at upper or proximal end of hollow tube and pushed oradvanced axially down interior of hollow tube, thereby urging or pushingor advancing the bone graft material down the hollow tube 2 towardfusion cage 60. Bone graft then proceeds into the fusion cage 60 wherebyit at least substantially fills fusion cage 60 interior and furtherengages fusion cage internal ramps 72 and emits bone graft materialthrough fusion cage first opening pair 65 and fusion cage second openingpair 67 and thus enters surgical area (e.g. a spinal surgical area).Upon sufficient user (i.e. surgeon) selectable injection of bone graftmaterial into surgical site and fusion cage 60, the plunger 12 isretracted and removed from the hollow tube 2 by opposite axial movement,i.e. by moving the plunger 12 away from the fusion cage 60. The funnel30 may then be optionally removed. Next, the ejection tool 140 isinserted into hollow tube 2 at upper or proximal end Ejection tool 140is advanced until ejection tool second end 152 engages fusion cagecollar face 93, whereupon downward force is applied to push fusion cage60 from engagement with hollow tube 2. As discussed, ejection toolsecond end 152 is configured such that it may not travel past or intothe fusion cage. When sufficient axial force is applied to the ejectiontool 140 in the direction of the fusion cage 60, the interference fitthat secures the fusion cage 60 (at fusion cage collar 92) to hollowtube 2 (at second end 8 of hollow tube) is overcome and the fusion cage60 is released or disengaged from the hollow tube 2. The engagement tool140, and the hollow tube 2 in which it is inserted, are then removedfrom the surgical site, leaving a fusion cage at least substantiallyfilled with bone graft and a surgical site also at least substantiallyfilled with bone graft.

In one embodiment, all or a portion of fusion cage collar 92 is of amaterial different than the remainder of the fusion cage 60, e.g.comprising a metal alloy. In one embodiment, a portion of the distal endof the hollow tube 2 is of a material different than the remainder ofthe hollow tube 2, e.g. comprising a metal alloy. In one embodiment, aportion of the distal end of the ejection tool is comprised of a metalalloy.

In one embodiment of the device, the tip of the hollow tube and/orfusion cage may separate under a threshold pressure as applied axiallyfrom the inside of the hollow tube or fusion cage respectively. Such auser-selected threshold would allow bone graft material to enter thesurgical site if bone graft material becomes clogged in the hollow tubeand/or fusion cage.

Referring now to FIGS. 49-62, various embodiments and components of afusion cage 60 with expandable fusion cage feature are depicted.Generally, the fusion cage 60 comprises an upper plate 200, lower plate210, front block 220, rear block 230, and expansion screw 240. Byrotating the expansion screw 240, each of the front block 220 and rearblock 230 advance toward the center of the fusion cage 60 whilesimultaneously advancing each of the lower plate 210 and upper plate 220away from the center of the fusion cage 60, thereby expanding theoverall height of the fusion cage 60. Each of the unexpanded state ofthe fusion cage 60 and expanded state of the fusion cage 60 areunderstood most immediately by comparing FIGS. 49A and 50A,respectively. The fusion cage 60 may be expanded in a scalable manner toa maximum threshold height value. At the maximum threshold height valueof the fusion cage 60, each of the front block 220 and rear block 230are unable to continue to advance toward the center of the fusion cage60 (such a state is shown as FIG. 50A). It is noted that in theembodiments of FIGS. 49-60, the lower plate 210 and upper plate 220remain substantially parallel in all configurations. Stated another way,the lower plate 210 and upper plate 220 remain substantially parallel inthe unexpanded fusion cage 60 state (e.g. FIG. 49A), in the maximumthreshold height value expanded state of the fusion cage 60 (e.g. FIG.50A), and in all states in between. In contrast, in the fusion cage 60embodiment of FIGS. 61A-B, the lower plate 210 and upper plate 220maintain a relative vertical wedge angle α, and in the embodiment ofFIGS. 62A-B, the lower plate 210 and upper plate 220 maintain a relativehorizontal wedge angle β.

Expansion screw 240 comprises expansion screw head 242, expansion screwtip 244 and expansion screw disk 246. The expansion screw 240rotationally engages each of the front block 220 via front blockaperture 227 and rear block 230 via rear block aperture 237. Theexpansion screw disk 246 engages each of the upper plate 200 via upperplate slot 206 and the lower plate 210 via lower plate slot 216. Theexpansion screw 240 is configured with opposing screw threads on eachside of expansion screw disk 246. Each of the front block aperture 227and rear block aperture 237 are tapped to accept the expansion screw 240threads. As such, as the expansion screw 240 is rotated, each of theopposing screw threads engage each of the front block aperture 227 andrear block aperture 237 and advance the respective front block 220 andrear block 230 toward the center of the fusion cage 60. As provided inFIGS. 57A-C, expansion screw 240 comprises left hand threads on a firstportion of expansion screw 240 proximal to the expansion screw head 242and right hand threads on a second portion of expansion screw 240 distalto the expansion screw head 242. Thus, the left hand threads engage therear block aperture 237 and the right hand threads engage the frontblock aperture 227. The left hand and right hand threads are symmetricalalthough in opposite directions such that rotation of the expansionscrew 240 results in equal movement of each of the front block 220 andrear block 230. Stated another way, the operation of the expansion screw240 with respect to the front block 220 and rear block 230 is such thateach block advances toward (or retreats from) the center of the fusioncage 60 in equal amounts or distance with rotation of the expansionscrew 240.

In an alternate embodiment, the thread configurations (and respectivetapped apertures) are reversed. The expansion screw head 242 is fittedwith a star terminus so as to engage a star (a.k.a. Torx™) screwdriver.In other embodiments, the expansion screw head 242 is fitted with a starscrewhead (i.e. female, i.e. receptor, end) so as to engage a starscrewdriver (i.e. a male screwdriver.) In other embodiments, any meansof screw drive known to those skilled in the art may be employed, toinclude slot or regular, Phillips, pozidriv, square, Robertson, hex, hexsocket, tri-wing, spanner head, clutch, double-square, triple-square,polydrive, spline drive, double hex, Bristol and pentalobular.

Front block 220 comprises front block upper rail 222, front block lowerrail 224, front block nose 225, front block ramp 226 and front blockaperture 227. As described above, front block aperture 227 is tapped toengage the threads of expansion screw 240. Each of front block upperrail 222 and front block lower rail 224 engage, respectively, upperplate track 205 and lower plate track 215. Such a configuration orarrangement may be referred to as a dovetail joint slider. As theexpansion screw is rotated, front block upper rail 222 moves or slideswithin upper plate track 205 toward the center of fusion cage and frontblock lower rail 224 moves or slides within lower plate track 215 towardthe fusion cage. Because of the wedged-shaped geometry of each of thefront block 220 and rear block 230, such movement toward the center ofthe fusion cage 60 results in an expansion (in height) of the fusioncage 60. Such movement also causes a reduction in the length of thefusion cage 60, in that the front block nose 225 retreats to theinterior of the fusion cage 60, thereby leaving the upper plate front201 and lower plate front 211, or the expansion screw tip 244, to definethe most distal end of the fusion cage 60. Such a change in fusion cage60 length is apparent by comparing, for example, FIGS. 49A and 50A. Inone embodiment, the expansion screw tip 244 is configured such that,when the fusion cage 60 is in a maximum expansion state, the expansionscrew tip 244 does not extend beyond a plane between the most distal endof the upper plate front 210 and lower plate front 211. It is noted thatin all states of expansion of the fusion cage 60, no aperture is formedat the nose of the fusion cage 60, e.g. between the front block 220 andeach of the upper plate 200 and lower plate 210. Stated another way, inall states of expansion of the fusion cage 60, to span unextended state(e.g. FIG. 49a ) and maximum extended state (e.g. FIG. 50A), no path foregress of material (e.g. bone graft) is provided from the interior ofthe fusion cage 60 through the front or nose area (i.e. in alongitudinal direction.) In an alternate embodiment, the front block 220is configured with one or more apertures, e.g. on one or more of frontblock ramp 236, so as to allow a path for said egress.

Front block 220 is symmetrical about a vertical plane (i.e. a planerunning parallel to each of front block upper rail 222 edge and frontblock lower rail 224 edge longitudinal axes and bisecting front blockaperture 227 at 12 and 6 o'clock positions.) Front block is symmetricalabout a horizontal plane (i.e. a plane running parallel to each of frontblock upper rail 222 surface and front block lower rail 224 surface andbisecting front block aperture 227 at 3 and 9 o'clock positions.)

Rear block 230 comprises rear block groove 231, rear block upper rail232, rear block lower rail 234, rear block ramp 236, rear block aperture237, rear block aft 238 and rear block detent 239. As described above,rear block aperture 237 is tapped to engage the threads of expansionscrew 240. Each of rear block upper rail 232 and rear block lower rail234 engage, respectively, upper plate track 205 and lower plate track215. As the expansion screw is rotated, rear block upper rail 232 movesor slides within upper plate track 205 toward the center of fusion cageand rear block lower rail 234 moves or slides within lower plate track215 toward the fusion cage. Because of the wedged-shaped geometry ofeach of the rear block 230 and rear block 230, such movement toward thecenter of the fusion cage 60 results in an expansion (in height) of thefusion cage 60. The rear block aft 238 is configured such that when thefusion cage 60 is in an unexpended state (e.g. FIG. 49A), the rear blockaft 238 is flush with the edges of each of upper plate rear 202 andlower plate rear 212. In one embodiment, the expansion screw head 242 isconfigured such that, when the fusion cage 60 is in an unexpanded state,the expansion screw head 242 is flush with the edges of each of upperplate rear 202, lower plate rear 212 and rear block aft 238.

Rear block 230 is similarly symmetrical about the same relative axes asfront block 220. That is, rear block 230 is symmetrical about a verticalplane (i.e. a plane running parallel to each of rear block upper rail232 edge and rear block lower rail 234 edge longitudinal axes andbisecting rear block aperture 237 at 12 and 6 o'clock positions.) Rearblock is symmetrical about a horizontal plane (i.e. a plane runningparallel to each of rear block upper rail 232 surface and rear blocklower rail 234 surface and bisecting front block aperture 237 at 3 and 9o'clock positions.)

Upper plate 200 comprises upper plate front 201, upper plate rear 202,upper plate opening 203, upper plate surface texture 204, upper platetrack 205, upper plate slot 206, upper plate ridge 209 and plate tab217. Upper plate surface texture 204 is formed of consecutive ridges ina lateral orientation, i.e. left-right rather than fore-aft. Inalternate embodiments, the upper plate surface texture 204 is formed ina longitudinal direction, i.e. fore-aft rather than left-right. In otheralternate embodiments, the upper plate surface texture 204 is of otherconfigurations known to those skilled in the art, to comprise groovesand ridges. Upper plate opening 203 comprises a pair of oval race-trackopenings. In other embodiments, upper plate opening 203 is a singleopening, is of circular shape, is of rectangular shape, or other shapesknown to those skilled in the art and/or conventionally used in fusioncages. Upper plate 200 is symmetric about a vertical plane runninglongitudinally between the two upper plate openings 203 and the upperplate track 205.

Lower plate 210 comprises lower plate front 211, lower plate rear 212,lower plate opening 213, lower plate surface texture 214, lower platetrack 215, lower plate slot 216, lower plate ridge 219 and plate tab217. Lower plate surface texture 214 is formed of consecutive ridges ina lateral orientation, i.e. left-right rather than fore-aft. Inalternate embodiments, the lower plate surface texture 214 is formed ina longitudinal direction, i.e. fore-aft rather than left-right. In otheralternate embodiments, the lower plate surface texture 214 is of otherconfigurations known to those skilled in the art, to comprise groovesand ridges. Lower plate opening 213 comprises a pair of oval race-trackopenings. In other embodiments, lower plate opening 213 is a singleopening, is of circular shape, is of rectangular shape, or other shapesknown to those skilled in the art and/or conventionally used in fusioncages. Lower plate 210 is symmetric about a vertical plane runninglongitudinally between the two lower plate openings 213 and the lowerplate track 215.

When the fusion cage 60 is in the unexpanded state (e.g. FIG. 49A),upper plate ridge 209 and lower plate ridge 219 are in communication,i.e. are touching or substantially touching.

Upper plate 200 and lower plate 210 are identical, and are assembled toform the fusion cage 60 by positioning in opposite orientations. Statedanother way, upper plate 200 and lower plate 210 are positioned tomirror one another about a horizontal plane through the center andmiddle height of the fusion cage 60. Among other things, identical upperplate 200 and lower plate 210 allow fewer unique parts to be used toassemble the fusion cage 60, thereby reducing costs, reducingcomplexity, and increasing robustness. Also, the fusion cage 60 designis such that the fusion cage remains structural stable and strong whileexpanded, to include when in the maximum expanded state, as enabled bythe type and degree of connections between the wedged blocks and theplates. That is, as enabled by the rail/track connections between theblocks and the plates, and also the adjacent surface connections of thewedged blocks (i.e. the area adjacent the rails of each block) and theplates.

The fusion cage 60 is a modular system in that components may becombined to cover several sizes and configurations. Although each of theupper plate 200 and lower plate 210 are identical, these paired platesmay be provided in several sizes. For example, as provided in FIGS.54A-F, a set of paired (i.e. one upper plate 200 and one lower plate210) plates may be provided in lengths of 26 mm, 32 mm and 36 mm. Also,the paired wedged blocks (i.e. a front block 220 and a rear block 230)may be provided in assorted sizes, e.g. an 8 mm and an 11 mm size, asdepicted in FIGS. 55A-E. Lastly, the expansion screw 240 may be providedin various configurations, as provided in FIGS. 57A-C, to matchcombinations of paired plates and paired wedged blocks. In oneembodiment, the fusion cage 60 may be constructed to range in size from8×26 mm to 14×36 mm.

In one embodiment, the expansion screw 240 comprises stainless steel andtitanium, and the upper plate 200 and lower plate 210 comprise stainlesssteel, titanium and polyether ether ketone (PEEK.)

Additional components that are configured to engage the fusion cage 60are provided in FIGS. 63-72. Generally, the additional componentscomprise those that allow the fusion cage 60 to be positioned at orwithin a surgical site, to expand and/or contract the fusion cage 60,deliver bone graft material within the fusion cage 60 and to thesurrounding surgical site, and detach the fusion cage.

With attention to FIGS. 63-69, a fusion cage 60 with expandable fusioncage feature, as described above, is depicted with an installer/impactor250 component. The installer/impactor 250 comprises installer/impactortip 252, installer/impactor aperture 253, installer/impactor ridge 254,installer/impactor channel 255, installer/impactor ramp 256 andinstaller/impactor handle 258. The installer/impactor aperture 253 isconfigured to engage the rear block aperture 253 and theinstaller/impactor ridges 254 are configured to engage the rear blockdetent 239; once these elements are engaged, the fusion cage 60 may beaccurately and reliable positioned at the surgical site. Theinstaller/impactor handle 258, with integrated striking plate, may beused to assist in guiding the fusion cage 60 into place, and furtherallows a “persuading” with a mallet. The installer/impactor handle 258attaches in place with, for example, a ball detent or similar featurethat secures the installer/impactor handle 250 in place yet allows quickand easy removal.

FIG. 65A details the installer/impactor 250 engaged with the fusion cage60, the fusion cage 60 in an unexpanded state. FIG. 65B details the samesystem and configuration of FIG. 65A, except that the expansion driver260, with expansion driver handle 268, is engaged with the fusion cage60. More specifically, the expansion driver 260, which fits within theinstaller/impactor 250, engages the expansion screw head 242 (e.g. theexpansion screw head 242 is a male star or Torx™ screw head that engageswith the female star or Torx™ screwdriver end of the expansion driver260.) FIG. 66 details the installer/impactor 250 engaged with the fusioncage 60, the fusion cage 60 in an expanded state (as a result of theexpansion driver 260 engaging the expansion screw head 242 and, throughrotation of the expansion screw head 242, expanding the fusion cage 60),and the hollow tube 2 fitted over the installer/impactor 250.

After the fusion cage 60 is expanded to the desired degree, i.e. height,the expansion driver 260 disengages from the expansion screw head 242and is removed. The hollow tube 2 is then slid downward or distally soas to engage the fusion cage 60, and the installer/impactor 250 must beremoved (so as to allow bone graft material to be delivered via hollowtube 2 into the fusion cage 60 and the surrounding surgical site.) FIG.67 details the installer/impactor 250 engaged with the fusion cage 60,the fusion cage 60 in an expanded state, and the hollow tube 2 fittedover the installer/impactor 250 and engaged with the fusion cage 60;this is the configuration of the integrated expandable fusion cage andbone graft delivery device when the installer/impactor 250 must beremoved so as to enable bone graft delivery. In an alternate embodiment,the installer/impactor 250 is not used, and instead the hollow tube 2 isused to position the fusion cage 60 by way of the hollow tube externalramp 280 and/or hollow tube notch 282. The hollow tube external ramp 280may form a press-fit with the fusion cage 60. The hollow tube may alsoengage the fusion cage 60 via the hollow tube notch 282, the hollow tubenotch 282 configured to engage the rear block aft 238 portion above andbelow the rear block aperture 237.

FIGS. 68A-B detail a means with which the installer/impactor 250 may beremoved by use of removal pliers 270. The removal pliers 270 areconfigured to engage the first end 6 of hollow tube and the proximal endof the installer/impactor 250, so as to pull the installer/impactor 250from engagement with the fusion cage 60. Note that theinstaller/impactor 250 is configured to allow the installer/impactor tip252 to spread apart over the rear block detent 239 groove, asfacilitated by the installer/impactor channel 255.

After the fusion cage 60 has been positioned in the surgical site andexpanded as required, bone graft material may be inserted into thefusion cage 60 and into the surrounding surgical site. FIG. 69 presentsan exploded perspective view of the fusion cage 60 with expandablefusion cage feature engaged with the hollow tube 2 component and funnel30 component, as configured to engage with the plunger 12 component. Asdescribed previously, bone graft material is placed into the funnel 30and advanced down the hollow tube 2 by the plunger 12, whereby bonegraft material flows into the fusion cage 60 and outward into thesurgical site via one or more of the upper plate openings 203, lowerplate openings 213, and lateral openings distal to the front block 230.

FIGS. 70-72 depict an alternate embodiment of hollow tube 2 and fusioncage 60 to enable the fusion cage 60 to be accurately and reliablypositioned at a surgical site. The hollow tube 2 comprises two pairs ofhollow tube slots 284, each with a hollow tube slot aperture 285 at thedistal end. Each hollow tube slot 284 is disposed at least partially onthe hollow tube external ramp 280. Each of the upper plate 200 and lowerplate 210 comprise a pair of plate tabs 217, each of which engages oneof the hollow tube slot apertures 285. When such an engagement occurs,the fusion cage 60 is slightly expanded as the hollow tube 2 is insertedinto the fusion cage 60. In this arrangement, as the fusion cage 60 isexpanded, the plate tabs 217 retreat or release from the hollow tubeslot apertures 285; however, the hollow tube 2 still engages orregisters with the fusion cage 60 via the hollow tube notches 282 whichremain engaged with the rear block aft 238.

In one embodiment, the expansion screw 240 is configured to lock atdefined expansion states of the fusion cage 60, to include at a maximumexpansion state (as defined, e.g. as the maximum height dimension ofwhich the fusion cage 60 may expand.)

In another embodiment, the fusion cage 60 with expandable cage featureis configured of modified and integrated embodiments of theafore-mentioned components. For example, FIG. 73 depicts a fusion cage60 with expandable fusion cage feature wherein the upper plate 200 andlower plate 210 are joined through a plate nose element 218 (“plate/noseelement”). These combined components are configured to form a firststate wherein a minimal vertical height is provided and/or a flatprofile is presented. Horizontal notches fitted between the upper plate200 and plate nose element 218, and between the lower plate element 210and plate nose element 218, enable the integrated upper plate 200, lowerplate 210 and plate nose element to expand upon engagement with anintegrated front block 220 and rear block 230 element. The integratedfront block 220 and rear block 230 element comprises a block spine 228(“block/spine element”) such that, when inserted into theafore-mentioned plate/nose element, the fusion cage 60 expands. In oneembodiment, each of the afore-mentioned integrated components would beheld in a pistol grip type insertion tool (as known to those skilled inthe art) which would allow placement of the unexpanded (i.e. thecollapsed) plate/nose element into the surgical site (e.g. a disk space)with the block/spine element staged right behind. Upon pulling a leveron the pistol grip tool, the plate/nose element would be inserted intothe block/spine element (in one embodiment, this insertion isfacilitated by upper plate track 205 and lower plate track 215 engagingrespective upper and lower rails of the block/spine element), therebyexpanding the plate/nose element and forming an expanded fusion cage 60.In one embodiment, a locking feature is provided such that theplate/nose and block/spine elements are secured or locked together. Inone embodiment, the insertion of this fusion cage 60 embodiment is byway of hollow tube 2 (e.g. the embodiment described in FIGS. 70-72). Inone embodiment of the fusion cage 60 as provided in FIG. 73, one or moreupper plate openings 203 and/or one or more lower plate openings 213 areprovided.

In one embodiment, no springs, such as wire springs, are employed toexpand the fusion cage 60. In one embodiment, other means, as known tothose skilled in the art, are used to expand the fusion cage 60, toinclude springs, gears, cams, magnetic, electrical, electro-mechanical,electro-magnetic, and optical.

The means and components disclosed may engage, integrate and/orcommunicate with the fusion cage 60 embodiments of the disclosure aswell as with traditional and conventional fusion cages. That is, thecomponents of the disclosure may be readily adapted to engageconventional fusion cages, including expandable fusion cages, of theprior art. More specifically, the hollow tube 2, installer/impactor 250,expansion driver 260, and/or plunger 12 may be adapted to engage fusioncages of the prior art. FIG. 74 provides a representative depiction ofadaptations of components of the disclosure so as to engage conventionalfusion cages, both fixed or static fusion cages and expandable fusioncages.

In one embodiment, the bone graft delivery system of the disclosure mayengage with an expandable fusion cage of the prior art. For example, thehollow tube 2 may be configured to engage the prior art (expandable)fusion cage 400 shown by, for example, geometric sizing of the hollowtube first distal opening 8, and/or fitting the hollow tube first distalopening 8 with a malleable portion that may be compressed and/orexpanded so as to engage the prior art (expandable) fusion cage 400,and/or fitting to an adaptor 300 portion. Additionally, theinstaller/impactor 250 may be adapted (e.g. to use the sameconfiguration of expansion end as that of the depicted fusion cage) tocommunicate with the end portion of the prior art (expandable) fusioncage 400 so as to enable the expansion of the prior art (expandable)fusion cage 400. The prior art (expandable) fusion cage 400 may also beengaged with one or more components of the disclosure, e.g. the hollowtube 2 and/or installer/impactor 250.

In one embodiment of the fusion cage 60, the fusion cage of the priorart is adapted wherein one or more of the upper plate 200 and/or lowerplate 210 is adapted to fit on paired opposite sides of the fusion cage.

In another embodiment, the bone graft delivery system of the disclosuremay engage with an unexpandable fusion cage of the prior art. The hollowtube 2 is configured to engage the prior art (unexpandable) fusion cage400 shown by, for example, geometric sizing of the hollow tube firstdistal opening 8, and/or fitting the hollow tube first distal opening 8with a malleable portion that may be compressed and/or expanded so as toengage the prior art (expandable) fusion cage 400, and/or fitting to anadaptor portion 300.

FIG. 74 depicts the bone graft delivery system of the disclosure, asengaged with an unexpandable fusion cage of the prior art, specificallyan unexpandable fusion cage provided in US2012/0065613 and/orhttp://thompsonmis.com/node/23, incorporated by reference in entirety.The hollow tube 2 is configured to engage the prior art (unexpandable)fusion cage 400 shown by, for example, geometric sizing of the hollowtube first distal opening 8, and/or fitting the hollow tube first distalopening 8 with a malleable portion that may be compressed and/orexpanded so as to engage the prior art (expandable) fusion cage 400,and/or fitting to an adaptor portion 300 (as shown).

In one embodiment, the adaptor 300 comprises at least two forked tinesto engage, for example, exterior surfaces of a fusion cage. In oneembodiment, the adaptor 300 forms an angled tool, that is, the adaptor300 and the hollow tube 2 are not aligned or linear. In anotherembodiment, the adaptor 300 forms an angled tool relative to a fusioncage when engaged with a fusion cage, that is, the adaptor 300 and thehollow tube 2 are aligned or linear but are not in alignment with anengaged fusion cage.

In one embodiment, the fusion cage 60 is actuated, e.g. the expansionscrew 240 is operated, remotely, e.g. through electrical means, magneticmeans or other means known to those skilled in the art, during surgeryor post-operative. The later situation, i.e. post-operative, enablesadjustment of the height of the fusion cage 60 after surgery. In oneembodiment, the fusion cage e.g. the expansion screw is operated ormanipulated by way of additional devices to comprise a servo-motor.

In one embodiment, the fusion cage 60 is used in applications comprisingL-LIF, A-LIF, Corpectomy adaptation, deformity correction and increasinglordosis.

In one embodiment, the expansion screw 240, comprising a left hand and aright hand threaded screw portion and a central disk, engages twoopposing blocks at a 30 degree ramp angle with a dovetail joint. As theblocks are drawn in, the cage plates are forced outward (in the verticaldirection). The narrow disk at the center of the screw registers in theslots of the cage plates to keep the plates from shifting fore/aft,reducing if not eliminating binding of the mechanism.

In one embodiment, at least some of the fusion cage is manufacturedusing 3-D printing technologies, metal additive manufacturing (AM),subtractive machining and/or direct metal laser sintering (DMLS) and maybe provided a porous coating. In one embodiment, the fusion cage 60comprises one or more surfaces, especially exterior surfaces, with poresso as to, for example, promote osseointegration. The article “EOS Teamswith Medical Implant Designer to Advance 3D Printing in Medicine”published Oct. 17, 2012 in Graphic Speak is incorporated by reference inentirety.

In one configuration, the fusion cage comprises a titanium alloy, suchas Ti6AL4V and/or lattice structures, the lattice structures coveringall or at least part of one or more apertures of the fusion cage 60. Inone configuration, the lattice structures in FIG. 82, hereinincorporated by reference in entirety.

In one configuration, the hollow tube 2 is configured such that itsdistal upper and lower interior surfaces have grooves to engage theupper and lower portions of the rear cage actuating wedge. The screwtool, fitting inside the cannula, is still used to expand the cage. Onceexpanded, the screw tool is removed. Then BG material is inserted usingthe cannula/plunger scheme. The screw tool is put back in to engage theexpandable screw and hold the fusion cage in place. The modified(interior grooved) cannula is pulled away from the cage with the screwtool providing an opposing force to the cage. The screw tool is thenremoved. Furthermore, the distal end of the modified cannula may be madeof an elastic material so that, if initially engaged with the cage incompression, it expands as the cage expands to provide a sealed fit withthe cage as the cage expands, thereby allowing a clean flow of BGmaterial into the cage i.e. no back-flow.

In one embodiment, one or more alignment markers are placed on thefunnel, e.g. lines at 0 degree and 180 degree. In one embodiment, one ormore clamps are applied to the hollow tube for additional support and/orstability. The clamps may be, e.g. scissor-type clamps. In oneembodiment, all or a portion of the plunger, hollow tube, fusion cageand ejection tool comprise a thermoplastic polycarbonate such as Lexan™.In one embodiment, the fusion cage comprises a different material thanone or more of the hollow tube, plunger and ejection device. In oneembodiment, the plunger comprises an elastic portion and elastic sealwhich functions, among other things, to restrict wiggle of the plungerwhen moving through the hollow tube. In one embodiment, one or moreportions of the device are manufactured via sonic welding, and/orcomprise a sonic weld. For example, the tip of the hollow tube and/orfusion cage may be sonic welded or comprise a sonic weld.

In one embodiment of the device, the width of the hollow tube secondexterior surface 5 is between 10 and 14 mm. In a preferred embodiment,the width of the hollow tube second exterior surface 5 is between 11 and13 mm. In a most preferred embodiment, the width of the hollow tubesecond exterior surface 5 is between 11.5 mm and 12.5 mm. In a preferredembodiment, the width of the hollow tube second exterior surface 5 is 12mm.

In one embodiment of the device, the width of the hollow tube firstexterior surface 3 is between 6 and 10 mm. In a preferred embodiment,the width of the hollow tube first exterior surface 3 is between 7 and 9mm. In a most preferred embodiment, the width of the hollow tube firstexterior surface 3 is between 7.5 mm and 8.5 mm. In a preferredembodiment, the width of the hollow tube first exterior surface 3 is 8mm.

In one embodiment of the device, the ratio of the width of the hollowtube second exterior surface 5 and the width of the hollow tube firstexterior surface 3 is between 1.7 and 1.3. In a preferred embodiment,the ratio of the width of the hollow tube second exterior surface 5 andthe width of the hollow tube first exterior surface 3 is between 1.6 and1.4. In a most preferred embodiment, the ratio of the width of thehollow tube second exterior surface 5 and the width of the hollow tubefirst exterior surface 3 is between 1.55 and 1.45. In one embodiment,the ratio of the width of the hollow tube second exterior surface 5 andthe width of the hollow tube first exterior surface 3 is 1.5.

In one embodiment of the device, the width of the interior of the hollowtube major axis (located adjacent the second exterior surface 5) isbetween 9 and 13 mm. In a preferred embodiment, the width of theinterior of the hollow tube major axis is between 10 and 12 mm. In amost preferred embodiment, the width of the interior of the hollow tubemajor axis is between 10.5 mm and 11.5 mm. In a preferred embodiment,the width of the interior of the hollow tube major axis is 11 mm.

In one embodiment of the device, the width of the interior of the hollowtube minor axis (located adjacent the first exterior surface 3) isbetween 5 and 9 mm. In a preferred embodiment, the width of the interiorof the hollow tube minor axis is between 6 and 8 mm. In a most preferredembodiment, the width of the interior of the hollow tube minor axis isbetween 6.5 mm and 7.5 mm. In a preferred embodiment, the width of theinterior of the hollow tube minor axis is 7 mm.

In one embodiment of the device, the ratio of the width of the interiorof the hollow tube major axis and the width of the interior of thehollow tube minor axis is between 1.7 and 1.3. In a preferredembodiment, the ratio of the width of the interior of the hollow tubemajor axis and the width of the interior of the hollow tube minor axisis between 1.6 and 1.4. In a most preferred embodiment, the ratio of thewidth of the interior of the hollow tube major axis and the width of theinterior of the hollow tube minor axis is between 1.55 and 1.45. In oneembodiment, the ratio of the width of the interior of the hollow tubemajor axis and the width of the interior of the hollow tube minor axisis 1.5.

It should be noted that the rectangular configuration of the hollow tubeaffords several advantages over conventional circular configuration. Forexample, for a surgical area with smallest dimension set at a width of 8mm with thickness dimension 0.5 mm, a conventional circular device (withresulting interior diameter of 7 mm or a radius of 3.5 mm) would realizea surface area of 38.48 mm.sup.2. Applicants' device would carryinterior dimension of 7 mm by 11 mm for a surface area of 77 mm, anincreased surface area factor of 2.0, thereby resulting in more bonegraft material delivery, because, among other things, a given volume ofbone graft encounters less surface area of the interior of a particulardevice which results in, among other things, reduced chance of jammingof bone graft material within the device.

In one embodiment, a one or more edges of the device are rounded. Forexample, the exterior edges of the hollow tube are rounded, and/or theinterior edges of the hollow tube are rounded (in which case the edgesof the plunger, at least at the plunger distal end, are identicallyrounded to ensure a congruous or conformal fit between the edges of theplunger and the interior of the hollow tube so as to, among otherthings, urge the majority of bone graft material to move through thehollow tube).

In one embodiment, the handle 16 of plunger is a planar disk shape, asdepicted in FIG. 23. In another embodiment, handle 16 is not planar. Forexample, handle 16 is angled so as to conform to interior of funnel 30when the plunger 12 is fully inserted into hollow tube 2.

In one embodiment, the hollow tube distal interior ramp surfaces 9A arelinear in shape, that is, forming a triangle in cross-section. Inanother configuration, the hollow tube distal interior ramp surfaces 9Aare of any shape that urges egress of bone graft material contained inthe hollow tube to exit the interior of the hollow tube through the pairof first distal openings 7 of the device 1.

A bone graft tamping device may also be provided, which is adapted to betelescopically inserted into the hollow tube after the plunger isremoved from the hollow tube. The bone graft tamping device, accordingto this embodiment, may include one or more longitudinal channels alongthe outer circumference of the bone graft packer for permitting anytrapped air to flow from the bone graft receiving area to the graspableend of the hollow tube during packing of bone graft. The bone graftpacker may further include a handle at one end designed ergonomicallyfor improving ease of use. The bone graft packer in this embodimentthereby facilitates packing of bone graft within the hollow tube.

The hollow tube may also be fitted with a passageway wherein a surgicaltube or other device may be inserted, such as to deliver a liquid to thesurgical area or to extract liquid from the surgical area. In such anembodiment, the plunger is adapted in cross-section to conform to thehollow tube's cross-section.

In another embodiment of the present invention, a kit of surgicalinstruments comprises a plurality of differently sized and/or shapedhollow tubes and a plurality of differently sized and/or shapedplungers. Each of the plungers correspond to at least one of the hollowtubes, whereby a surgeon may select a hollow tube and a plunger whichcorrespond with one another depending upon the size and shape of thegraft receiving area and the amount or type of bone graft to beimplanted at such area. The corresponding hollow tubes and plungers areconstructed and arranged such that bone graft can be placed within thehollow tubes with the plungers, and inserted nearly completely into thehollow tubes for removing substantially all of the bone graft materialfrom the hollow tubes, such as in the preferred embodiments for theplunger described above. The use of more than one hollow tube/plungercombination permits at least two different columns of material to beselectably delivered to the targeted site, e.g. one of bone graftmaterial from the patient and another of Bone Morphogenetic Protein(BMP), or e.g. two different types of bone graft material or onedelivering sealant or liquid. Also, one or both hollow tubes could bepreloaded with bone graft material.

The kit of surgical instruments may comprise a plurality of differentlysized and/or shaped graft retaining structures, each corresponding to atleast one hollow tube and at least one plunger.

The bone graft receiving area can be any area of a patient that requiresdelivery of bone graft. In the preferred embodiment, the bone graft isdelivered in a partially formed manner, and in accordance with anotheraspect of the present invention, requires further formation afterinitial delivery of the bone graft.

Another embodiment of the present invention provides a method by which ahollow tube and a plunger associated with the hollow tube are providedto facilitate delivery of the bone graft to a bone graft receiving area.

According to one embodiment, the present invention provides a bone graftdelivery system, by which a hollow tube and/or plunger assembly may beprepared prior to opening a patient, thus minimizing the overall impactof the grafting aspect of a surgical implantation or other procedure.Moreover, the hollow tube may be made to be stored with bone graft in itfor a period of time, whether the tube is made of plastic, metal or anyother material. Depending upon the surgical application, it may bedesirable to only partially fill the tube for storage, so that a plungercan be at least partially inserted at the time of a surgery.

Thus, the integrated fusion cage and graft delivery device may eithercome with a pre-filled hollow tube, or a non-filled hollow tube, inwhich the surgeon will insert bone graft received from the patient(autograft), or from another source (allograft). In either case, thesurgeon may first remove any wrapping or seals about the hollow tube,and/or the pre-filled bone graft, and insert the hollow tube into thepatient such that the second end of the hollow tube is adjacent the bonegraft receiving area. Once the hollow tube is in place, and the openingat the second end of the hollow tube is oriented in the direction of thedesired placement of bone graft, the surgeon may then insert the secondend of the plunger into the opening at the first end of the hollow tube,and begin pressing the second end of the plunger against the bone graftmaterial in the hollow tube. In this fashion, the plunger and hollowtube cooperate similar to that of a syringe, allowing the surgeon tosteadily and controllably release or eject bone graft from the secondend of the hollow tube as the plunger is placed farther and farther intothe opening in the hollow tube. Once the desired amount of bone grafthas been ejected from the hollow tube (for in some instances all of thebone graft has been ejected from the hollow tube) the surgeon may removethe plunger from the hollow tube, and complete the surgery. In certainoperations, the surgeon may elect to place additional bone graft intothe hollow tube, and repeat the steps described above. Furthermore, thepre-filled bone graft elements may be color-coded to readily identifythe type of bone graft material contained therein.

According to the embodiment described in the preceding paragraph, thepresent invention may be carried out by a method in which access isprovided to a graft receiving area in a body, bone graft is placed intoa hollow tube having a first end and a second end, the hollow tube,together with the bone graft, is arranged so that the first end of thehollow tube is at least adjacent to the graft receiving area and permitslateral or nearly lateral (in relation to the longitudinal axis of thehollow tube and plunger assembly) introduction of bone graft to thegraft receiving area. This method prevents loss of bone graft due toimproper or limited orientation of the integrated fusion cage and graftdelivery device, and further allows a user to achieve insertion of adesired quantity of bone graft by way of the contoured plunger andhollow tube configuration described according to preferred embodimentsherein.

The method of the present invention may also be carried out by providinga hollow tube having a first end and a second end, constructed so thatit may receive a measurable quantity of bone graft, and so that thefirst end may be arranged at least adjacent to a bone graft receivingarea, and so that bone graft can be delivered from the first end of thehollow tube through the second end of the hollow tube and eventually tothe bone graft receiving area upon movement of the plunger in agenerally downward direction through the hollow tube (i.e., in adirection from the first end to the second end). According to thisembodiment, a graft retaining structure may also be provided for use inconnection with the contoured edge of the plunger, such that the graftretaining structure is positioned between the contoured edge of theplunger and the bone graft, but which is adhered to the bone graft andremains at the graft receiving area following removal from the hollowtube. In one embodiment, the bone graft is provided in discrete packagesor containers. Furthermore, this graft retaining structure may also beemployed with another tool, such as a graft packer, which is employedeither before or after the hollow tube is removed from the graftreceiving area.

In another embodiment, the one or more plungers corresponding to the oneor more hollow tubes are positioned with distal ends near the proximateend of the horizontal tube before use, said plungers having a detent toretain plunger in ready position without undesired movement beforesurgeon chooses which one or more plungers to extend through hollowhorizontal tube and deliver bone graft material and/or desired materialto the surgical area.

According to another embodiment of the present invention, a hollow tubeand plunger assembly is provided in which the hollow tube and/or theplunger assembly is disposable. Alternatively, the tube may be made of abiocompatible material which remains at least partially in the patientwithout impairing the final implantation. Thus, the hollow tube may beformed from a material that is resorbable, such as a resorbable polymer,and remain in the patient after implantation, so as not to interferewith the growth of the bone or stability of any bone graft or implant.

The current design preferably comprises a hollow tubular membercomprising a rounded edge rectangular shaft, which may be filled or ispre-filled with grafting material. The loading is carried out by theplunger. The rectangular design is preferable as it allows the largestsurface area device to be placed into the annulotomy site of a disk, butin other embodiments may be formed similar to conventional round shafts.The other preferred feature includes a laterally-mounted exit site forthe graft material. The combination of this design feature allowsdirection-oriented dispersion of the graft material. This allowsejection of the graft material into an empty disk space as opposed tobelow the hollow tube, which would tend to impact the material and notallow its spread through a disk space.

Another feature of this design is that a rectangular design allows theuser to readily determine the orientation of the device and thereby thedirection of entry of the bone graft material into the surgical area.However, such a feature may be obtained alternatively through exteriormarkings or grooves on the exterior on the hollow tube. Such exteriorgrooves or markings would allow use of a range of cross-sections for thedevice, to include a square, circle, or oval while allowing the user toreadily determine the orientation of the device relative to thedirection of entry of the bone graft material into the surgical area.

A further feature of this design is that an anti-perforation footing orshelf is paced on the bottom of the hollow tube to prevent annularpenetration and/or injury to the patient's abdomen or other anatomyadjacent the bone graft receiving area.

Another alternative embodiment to the design described herein includes aremovable funnel attachment. This allows easy loading of the cannulawith the funnel and with its removal easy visualization of the operatingsite without visual blockage through the microscope.

In another embodiment of the invention, all or some of the elements ofthe device or sections of all or some of the device may be disposable.Disposable medical devices are advantageous as they typically havereduced recurring and initial costs of manufacture.

In another embodiment of the device, the distal tip or end of theplunger device is composed of a different material to the rest of theplunger, so as the material at the distal end of the plunger issponge-like or softer-than or more malleable than the rest of theplunger so as upon engagement with the interior distal end of the hollowtube, the distal end of the plunger substantially conforms to theinterior configuration of the hollow tube. Similarly, the plunger distalend may be made of a material that is adaptable to substantially conformto the interior shape of the distal end of the hollow tube. Suchconfigurations enable substantially all of the material contained withinthe plunger to be delivered to the targeted site.

Another alternative embodiment to the design described herein includes anavigation aid on one or more surfaces of the tubular body to permitsurgeon to know how far the device has been inserted or to ensure properalignment relative to a transverse bone graft delivery site (i.e. discspace). Such capability is particularly important when the patient orsurgical area is not positioned immediately below the surgeon, ormultiple procedures are being performed. A navigation aid allows moreimmediate and reliable locating of the surgical area for receiving ofbone graft material. In one embodiment, the hollow tube is scored ormarked or provides some affirmative indication, actively or passively,to the surgeon to indicate degree of delivery of the material, e.g. bonegraft material, to the delivery site, and/or position of the plungerelement. For example, the exterior of the hollow tube could becolor-coded and/or provided with bars. In another embodiment, a computerand/or electro-mechanical sensor or device is used to provide feedbackto the surgeon to indicate degree of delivery of the material, e.g.amount of cc's of bone graft material, to the delivery site, and/orposition of the plunger element.

In another alternative embodiment to the design described herein, theplunger could include an activation device, which is often in a liquidor semi-liquid state, and that may be injected once the semi-solidportion of the morphogenic protein has been displaced by the movement ofthe plunger through the tubular body. That is, the plunger pushes thedry material, and once completed has a bulb or other device on theusable end to insert the liquid portion of the activating agent throughthe inner lumen within the plunger to evacuate the liquid from theplunger and out an opening at the non-usable end of the plunger so as tocontact the dry material already inserted into the disc space).

In one embodiment of the device, all or portions of the device aremanufactured using 3-D printing techniques. In another embodiment, allor portions of the device are made by injection molding techniques.

In one embodiment, the ratio of the surface area of the bottom tip ofthe plunger is approximately half the surface area of the two lateralopenings at the distal portion of the hollow tube.

In one embodiment, the device includes a supplemental means of grippingthe device, such as a laterally extending cylindrically-shaped handlethat engages the hollow tube.

In one embodiment, the material inserted into the hollow tube is anon-Newtonian fluid. In one embodiment, the device is adapted to acceptand deliver compressible fluids. In another embodiment, the device isadapted to accept and deliver non-compressible fluids.

In one embodiment, the upper portion of plunger is fitted with one ormore protrusions, which extends from the surface of the plunger so as toengage the upper surface of the hollow tube, to prevent the plunger fromengaging the distal interior portion of the hollow tube. In oneembodiment, the upper portion of plunger is fitted with one or moreprotrusions to prevent the plunger from engaging the apex of the hollowtube distal interior ramp surface.

In one embodiment, the funnel attaches to the upper portion of thehollow tube by a bayonet connection. In one embodiment, the funnelattaches to the upper portion of the hollow tube by an interference fit.In one embodiment, the funnel attaches to the upper portion of thehollow tube by a threaded connection. In one embodiment, the funnelattaches to the upper portion of the hollow tube by a slot/grooveconnection.

In one embodiment, the second end of hollow tube has one hollow tubedistal opening. In one embodiment, the second end of hollow tube has twohollow tube distal openings located on opposite sides. In oneembodiment, the second end of hollow tube has no more than two openings,the openings located on opposite sides.

In one embodiment, after bone graft material is delivered to a surgicalsite, a cavity approximately defined by the volume engaged by the devicewhen inserted into the surgical site is left in the surgical site uponremoval of the device from the surgical site. In one embodiment, theaforementioned cavity is then used as the site for insertion of a fusioncage.

The integrated fusion cage 60 with expandable cage feature provides anumber of unique and innovative features not provided by conventional ortraditional integrated fusion cages. For example, the integrated fusioncage with expandable cage feature of the disclosure is intentionally anddeliberately designed to receive bone graft material (or any materialsuitable for use in surgical applications, as known to those skilled inthe art) at its proximal end (i.e. the end generally facing the surgeonand/or the end opposite the end initially directed into a surgicalsite), such that the bone graft material flows into the fusion cage andalso flows out from the fusion cage into the surgical site. Suchfeatures as the interior ramps of the fusion cage (e.g. located withinthe interior of the hollow tube, and/or on the front and/or rear blocksof the fusion cage) function to direct received bone graft material intothe surgical site. Additionally, the features of the hollow tube andplunger wherein a greater volume of bone graft material may be reliably(e.g. not prone to blockage as is typical with most convention e.g.round hollow tubes or cannula systems) and readily delivered to asurgical site and/or a fusion cage are unique and not found in the priorart. Among other things, such features encourage improved surgicalresults by delivering more volume and coverage of bone graft material tothe surgical site. Also, such features minimize gaps in bone graftcoverage to include gaps between the fusion cage area and thesurrounding surgical site. Also, the features of the one or moreapertures of the fusion cage of the disclosure enable and encouragedelivery of bone graft material, as received by the fusion cage, intothe surrounding surgical site.

In contrast, conventional fusion cages, to include expandable fusioncages, do not provide such features and/or functions. For example, U.S.Pat. No. 8,852,242 to Morgenstern Lopez (“Lopez”), discloses a dilationintroducer for orthopedic surgery for insertion of an intervertebralexpandable fusion cage implant. The Lopez device does not allow receiptof bone graft material from its proximal end, or any end, in contrast tothe disclosed fusion cage and fusion cage/bone graft delivery system.That is, the Lopez proximal end includes an array of components, all ofwhich do not allow receipt of bone graft material. Furthermore, theLopez device requires an elaborate array of components, e.g. upper sideportion 240 of the upper body portion 202 and lower side portion 242 ofthe lower body portion 204, which also block any egress of bone graftfrom the inside of the Lopez fusion cage once deployed. Also, the Lopezwedges occupy the entire interior of the cage; there are no ramps todirect graft from the interior to the disk space. In short, the Lopezdesign is not made with bone graft delivery in mind, and indeed, cannotfunction to accept let alone deliver bone graft. Additionally,suggestions provided in the Lopez disclosure to deliver bone graft tothe surgical site would not provide the integrated and complete fusioncage and surgical site bone graft delivery of the invention, e.g. theLopez slot 918 of the Lopez lumen 916 and funnel assembly 910 at bestprovides limited delivery of bone graft material only before and afterinsertion of the Lopez fusion cage, and then only peripheral to thefusion cage. Also, it appears the Lopez device provides wedges 206 and208 of similar if not identical interior ramp angles. In contrast, incertain embodiments of the present invention the interior wedgedsurfaces of the invention, i.e., front block ramp 226 and rear blockramp 236, are not of the same configuration and/or shape, e.g. frontblock ramp 226 is of a curved profile and rear block ramp 236 is of alinear or straight-line profile. Among other things, the curved profileof the front block ramp 226 urges egress of bone graft as received bythe fusion cage 60.

In one embodiment of the fusion cage 60, no anti-torque structures orcomponents are employed. In one embodiment of the invention, the lateralsides of the fusion cage 60 are substantially open to, among otherthings, allow egress of bone graft material as received to the fusioncage. In one embodiment, the expansion screw 240 is configured with alocking mechanism, such that the fusion cage 60 may be locked at a setexpansion state. In one embodiment, such a locking mechanism is providedthrough a toggle device operated at or on the installer/impactor handle258.

In one embodiment, the front block ramp 226 and rear block ramp 236 areidentical and/or symmetrical.

In addition, it is contemplated that some embodiments of the fusion cage60 can be configured to include side portions that project therefrom andfacilitate the alignment, interconnection, and stability of thecomponents of the fusion cage 60.

Furthermore, complementary structures can also include motion limitingportions that prevent expansion of the fusion cage beyond a certainheight. This feature can also tend to ensure that the fusion cage isstable and does not disassemble during use.

In some embodiments, the expansion screw 240 can facilitate expansion ofthe fusion cage 60 through rotation, longitudinal contract of a pin, orother mechanisms. The expansion screw 240 can also facilitate expansionthrough longitudinal contraction of an actuator shaft as proximal anddistal collars disposed on inner and outer sleeves move closer to eachother to in turn move the proximal and distal wedged block memberscloser together. It is contemplated that in other embodiments, at leasta portion of the actuator shaft can be axially fixed relative to one ofthe proximal and distal wedge block members with the actuator shaftbeing operative to move the other one of the proximal and distal wedgemembers via rotational movement or longitudinal contraction of the pin.

Further, in embodiments wherein the engagement screw 240 is threaded, itis contemplated that the actuator shaft can be configured to bring theproximal and distal wedged block members closer together at differentrates. In such embodiments, the fusion cage 60 could be expanded to aV-configuration or wedged shape. For example, the actuator shaft cancomprise a variable pitch thread that causes longitudinal advancement ofthe distal and proximal wedged block members at different rates. Theadvancement of one of the wedge members at a faster rate than the othercould cause one end of the implant to expand more rapidly and thereforehave a different height that the other end. Such a configuration can beadvantageous depending on the intervertebral geometry and circumstantialneeds.

In other embodiments, the implant 200 can be configured to includeanti-torque structures. The anti-torque structures can interact with atleast a portion of a deployment tool during deployment of the fusioncage 60 implant to ensure that the implant maintains its desiredorientation. For example, when the implant is being deployed and arotational force is exerted on the actuator shaft, the anti-torquestructures can be engaged by a non-rotating structure of the deploymenttool to maintain the rotational orientation of the implant while theactuator shaft is rotated. The anti-torque structures can comprise oneor more inwardly extending holes or indentations on the rear wedgedblock member. However, the anti-torque structures can also comprise oneor more outwardly extending structures.

According to yet other embodiments, the fusion cage 60 can be configuredto include one or more additional apertures to facilitateosseointegration of the fusion cage 60 within the intervertebral space.The fusion cage 60 may contain one or more bioactive substances, such asantibiotics, chemotherapeutic substances, angiogenic growth factors,substances for accelerating the healing of the wound, growth hormones,antithrombogenic agents, bone growth accelerators or agents, and thelike. Indeed, various biologics can be used with the fusion cage 60 andcan be inserted into the disc space or inserted along with the fusioncage 60 The apertures can facilitate circulation and bone growththroughout the intervertebral space and through the implant. In suchimplementations, the apertures can thereby allow bone growth through theimplant and integration of the implant with the surrounding materials.

In one embodiment, the fusion cage 60 comprises an expandable cageconfigured to move a first surface vertically from a second surface byrotation of at least one screw that rotates without moving transverselywith respect to either said first or second surface, said first plateand second plate having perimeters that overlap with each other in avertical direction and that move along a parallel line upon rotation ofthe screw.

In one embodiment, the fusion cage 60 is stackable by any means known tothose skilled in the art. For example, each upper plate 200 may befitted with one or more notches on the lateral edges configured to fitwith one or more protrusions on each lower plate 210.

Surprisingly, while conventional practice assumed that the amount ofmaterial that would be required, let alone desired, to fill a prepareddisc space with bone paste (or BMP, etc.) would be roughly equivalent tothe amount of material removed from such space prior to inserting acage, a present inventor discovered that far more bone graft materialcan be—and should preferably be—inserted into such space to achievedesired fusion results. The reasons why this basic under appreciationfor the volume of bone graft necessary to achieve optimal fusion resultsvary, but the clinical evidence arrived at via practice of the presentinvention compellingly demonstrates that more than doubling of theamount of bone graft material (and in some cases increasing the amountby 200%, 300% or 400% or more) than traditionally thought necessary orsufficient, is extremely beneficial to achieving desired results fromfusion procedures.

The ramifications of this simple yet dramatic discovery (documented inpart below) is part of the overall inventive aspect of the presentinvention, as it has been—to date—simply missed entirely by thepracticing spine surgeons in the field. The prospect of reduced returnsurgeries, the reduction in costs, time, and physical suffering bypatients, as well as the volume of legal complaints against surgeons andhospitals due to failed fusion results, is believed to be significant,as the evidence provided via use of the present invention indicates avast reduction in the overall costs involved in both economic resources,as well as emotional capital, upon acceptance and wide-spread use of thepresent invention. Insurance costs should thus decrease as the presentinvention is adopted by the industry. While the costs of infusingincreased amount of bone graft materials into the space of a patient'sdisc may at first appear to increase the costs of an individualoperation, the benefits achieved thereby will be considerable, includingthe reduction of repeat surgeries to fix non-fused spines. Thus,regardless of the actual tools and devices employed to achieve the endresult of attaining up to 100% more bone graft material being utilizedin fusion operations, (as well as other surgeries where previouslyunder-appreciated bone graft material delivery volumes have occurred)one important aspect of the present invention is directed to theappreciation of a previously unrecognized problem and the solutionthereto, which forms part of the inventive aspects of the presentinvention described and claimed herein.

In one embodiment, at least twice the amount of disk material removedfrom a surgical site is replaced with bone graft material. In apreferred embodiment, at least three times the amount of disk materialremoved from a surgical site is replaced with bone graft material. In amost preferred embodiment, at least three and a half times the amount ofdisk material removed from a surgical site is replaced with bone graftmaterial.

EXPERIMENTAL RESULTS

The following experimental results are with respect to an apparatus andmethod for integrated delivery of bone graft material in a patient'sspine. These results are sample results and are not intended to limitthe invention.

Materials and Methods

During the time period from July 2010 through December 2012, a set ofpatients undergoing minimally invasive (MIS) transverse lumbar interbodyfusion (T-LIF) at the L4-5 and/or L5-S1 levels were studied for diskmaterial removed and BG delivered at each disk space during the surgicalprocedure. The diagnosis was spondylosis or spondylolisthesis in allpatients. A total of 63 patients with an average age of 56 years werestudied. There were 29 male and 34 female patients. Ninety-one diskspaces were analyzed. A single surgeon with the same surgical teamperformed all surgeries. The operations were carried out through a 22 mmcannula with microscopic control. The midline structures and spinousprocess attachments were left undisturbed. The disk space was debridedexhaustively using non-motorized, hand tools to bleeding subchondralbone. The debrided disk material was measured in a volumetric syringe.Bone Graft (BG) material consisting of silicated tricalcium phosphategranules and hyaluronic acid powder were mixed in a 1:1 ratio and localbone graft and bone marrow aspirate concentrate were added together toform a slurry. The slurry was measured volumetrically. Disk spacemobilization and distraction was carried out with serial impaction ofdistractor tools until appropriate disk height was achieved. Distractionranged from 8 mm to 14 mm, with the 10 mm or 12 mm height being mostcommonly observed.

The BG delivery tool of this disclosure was used to apply the BG slurryto the disk space. The embodiment had a rectangular cross section withthe same footprint as a small fusion cage (8 mm×12 mm). The tapered tipwas placed into the debrided disk space under microscopic control toallow for direct visualization, followed by the application of a snap-onfunnel for loading the BG. The BG slurry was then placed in the funneland the slurry was pushed into the disk space with the plunger. Thebiportal design of the delivery tool directed the slurry into thelateral areas of the prepared disk space, leaving a natural void for thefusion cage once the tool was removed. Once the disk space was filledentirely, the site of insertion was inspected for any BG material, whichmight have escaped the confines of the disk space. This material wasexcluded in the final measurement to ensure an accurate calculation ofBG delivery. Removal of the delivery tool provided an unobscured pathfor the fusion cage to be applied.

A polyether ether ketone, hollow interbody fusion cage of theappropriate size was then placed into the disk space. A minimallyinvasive, bilateral pedicle screw/rod system was applied prior to woundclosure. Average blood loss for the procedures was 127 ml+/−75 ml.

A two-tailed student's t-test was used to determine if any significantdifference existed between the volumes of disk material removed at L4-5versus L5-S1. The null hypothesis was that no significant differenceexisted between samples. Significance was set at p<0.05. The two-tailedt test was also used to determine whether a significant differenceexisted between volumes of BG delivery and disk material removed. Theformula [(BG delivered+graft volume of the fusion cage)/disk materialremoved] was used to generate the ratio of BG delivery versus diskmaterial removed.

In order to compare the volume of disk material removed during a T-LIFprocedure with a complete, surgical diskectomy, the volume of diskmaterial removed during L5-S1 anterior lumbar diskectomy was measuredvolumetrically. The L5-S1 disk was harvested and measured for patientsundergoing either anterior fusion or total disk replacement. Thematerial removed consisted of anterior and posterior annulus as well ascomplete nuclectomy, and represented more tissue (in terms of theannuli) than would be typically removed in a T-LIF procedure. There were29 anterior L5-S1 diskectomy patients. The age range, genderdistribution and diagnosis were the same as the T-LIF patients.

All study patients were followed up with anterior/posterior radiographsand a physical examination at 4 weeks, 12 weeks, 26 weeks and 52 weekspost surgery. A visual analog scale (VAS) for pain was obtained at eachvisit and an Oswestry Disability Index (ODI) was completedpreoperatively and at 26 weeks postoperatively.

Results

There were 58 L4-5 disk spaces and 33 L5-S1 disk spaces evaluated. Theaverage volumes of disk material harvested from L4-5 and L5-S1 were 4.1ml+/−2.2 ml and 2.8 ml+/−1.9 ml, respectively. The p-value for thestudent's two-tailed t-test was equal to 0.01, revealing a significantdifference in terms of disk material removed between L4-5 and L5-S1. Therange of volume was less than 1 ml to 14.5 ml. The comparison betweendisk material removed and BG material inserted at L4-5 or at L5-S1demonstrated a significant difference (p<<0.001).

BG volume applied to L4-5 was 9.8 ml+/−3.3 ml. At L5-S1 it was 8.6ml+/−3.2 ml. The p-value for the student's two-tailed t-test was equalto 0.07, trending to a significant difference in bone graft appliedbetween L4-5 and L5-S1. The combined average was 9.2 ml+/−3.0 ml. Thevolume of BG applied ranged from 4.5 ml to 19 ml. The formula of [(BGdelivered+graft volume of the fusion cage)/disk material removed]generated a surprising result: The amount of disk material removedcompared to the amount of BG placed in the disk space was not a 1:1ratio, as would have been empirically expected. At L4-5 the ratio was3.4+/−2.2 and at L5-S1 it was 4.7+/−2.7, as shown in FIGS. 34A-B,respectively. This was statistically significant with a p-value of 0.02.With respect to the entire study, the ratio of BG inserted relative todisk material removed revealed that on average 3.7+/−2.3 times as muchBG was inserted into the disk space as disk material removed. Thisfinding was even more dramatic with collapsed disk spaces where 1 ml ofdisk material harvest led to an average of 6.6 ml+/−0.9 ml of BGdelivery, as shown in FIGS. 35A-B. The volume of BG delivery wasasymptotically related to the volume of disk material removed with 12.3ml of disk material being delivered to a disk where 8.0 ml of disk wasremoved, as shown in FIGS. 35A-B.

The average volume of disk material removed during a T-LIF diskectomy atL5-S1 was 3.2 ml and the average volume of disk material from theanterior L5-S1 diskectomy was 8.1 ml. Dividing the average T-LIF volumeby the average anterior diskectomy (including annuli) volume revealedthat on average 34% of the disk material was removed at the time ofT-LIF at the L5-S1 disk space.

Because of the tapered tip of the BG delivery tool, it was possible toenter the most collapsed disk space without endplate injury. Thedelivery device did not jam with the application of the BG slurry. Theremovable funnel allowed direct visualization of the tool under themicroscope without obscuring its tip during insertion. Because thedelivery device applied BG out of its side portals, it provided anatural void for fusion cage insertion, and no cage jamming resultedduring impaction. BG delivery using the described tool took a fractionof the time (less than 2 minutes) usually devoted to depositing BG tothe disk space. There were no complications associated with the use ofthe BG delivery tool.

The average preoperative ODI measured 29+/−9 and the postoperative valuewas 21+/−8. A significant difference was not detected with p=0.06. TheVAS similarly improved with pre-operative score measuring 7.5+/−1.5 andpostoperative score 4.0+/−2.5. The postoperative VAS was statisticallysignificant relative to the corresponding preoperative value withp<0.05.

Pseudoarthrosis developed in 7 disks in 4 patients (7.6%). The patientswith 2-level pseudoarthrosis had a diagnosis of hypothyroidism. Thisdiagnosis was also present in one of the single level pseudoarthosispatients. The remaining pseudoarthrosis patients did not havediscernable risk factors (diabetes, tobacco consumption or obesity).

DISCUSSION

There is substantial variation in fusion rates after T-LIF surgery withpseudoarthrosis rates varying from 23.1% to 2.9%. The reasons for therange of successful arthrodesis vary from surgical technique, includingBG preparation and application, to the way in which a pseudoarthrosis isdiagnosed—direct surgical exploration or by radiographic means. Reasonwould dictate that the volume of BG delivered to a prepared disk spacewould contribute positively to successful arthrodesis with inadequategrafting leading to pseudoarthrosis. Using hand tools and the goal ofdisk space debridement, a conservative estimate of 34% of disk removalwas observed in this study at the L5-S1 level. This substantialdifference represents the different goals of the procedures and providesa baseline for general disk space debridement for T-LIF procedures.

The statistically significant difference between the amount of diskmaterial removed from L4-5 versus L5-S1 correlates with the commonlyobserved radiographic finding of disk height at L4-5 being greater thanthat of L5-S1. Likewise, BG delivery to L4-5 was greater relative to theL5-S1 disk space. Although direct volume of BG insertion was greater inL4-5 relative to L5-S1, the ratio (BG delivered/disk material removed)was higher at L5-S1 (4.7+/−2.7) than at L4-5 (3.4+/−2.2). This was astatistically significant difference (p<0.02) and corresponds with themore collapsed disk spaces demonstrating a higher percentage of BGdelivery (see FIGS. 34A-B).

On average, 3.7 times as much bone graft was applied to the debrideddisk space relative to disk material removed. This is explained by thefact that the disk space was collapsed at the time of diskectomy, andthen distracted and mobilized during the preparation process to adistracted height. This suggests that relying on an empiric 1:1 ratio ofdisk removal to BG insertion grossly under-fills the disk space andwould be an important contributor to pseudoarthrosis. This is anespecially important consideration in the most collapsed disk spacessince distraction to appropriate height in a non-collapsed disk reducesthe ratio to 8:12.3 (see FIG. 35A) or a 1:1.4 ratio.

The BG slurry used in this study consisted of a mixture of granularmaterial and liquid. This combination of materials does not behave as atypical, Newtonian (non-compressible) fluid. A non-Newtonian fluid willexude its fluid component as it is compressed, and the residual granularBG material occludes a conventional, cylindrical BG delivery device.

The BG delivery tool in this study revealed a number of advantages inthat it allowed for BG application in collapsed disc spaces due to itswedged tip, a process which is not possible with round-ended injectioncannulas. The increased cross sectional footprint relative to a roundcannula allowed considerably less friction of non-Newtonian fluidmaterial through the cannula, resulting in an increase in the BG flowdynamics, and eliminating jamming due to BG impaction. It is estimatedthat changing the cross-sectional area from 8 mm×8 mm to 8 mm×12 mmimproves the flow dynamics of a non-Newtonian fluid by 40%. The twosites for BG extrusion at the sides of the cannula tip double the exitzone surface area, further decreasing the resistance to flow of thegranular mixture. The removable funnel allowed direct visualization ofthe cannula as it was applied to the disk space without being obscuredby the funnel. The biportal expression of the BG material allowed graftinoculation of all prepared areas of the disk space and left a void forthe fusion cage. The applied BG delivery tool allowed refilling of thecannula without having to remove the device, resulting in decreasedpotential trauma to the adjacent nerve tissue.

The fusion rate in this study was 92.4% with three of thepseudoarthrosis patients having a diagnosis of hypothyroidism. This maybe related to abnormalities in bone metabolism associated in patientswith endocrinopathy. The other pseudoarthrosis patients did not haveapparent risk factors. Postoperative pain scores and functionalimprovement correlated with progression to arthrodesis.

In summary, preparation of the disk spaces at L4-S1 can deliver 34% ofthe disk volume during debridement. BG delivery was on average 3.7 timesthe volume of disk removal with a relatively higher ratio of BG beingdelivered to the more collapsed disk spaces. A novel BG delivery devicecan be used to dispense a volume of BG to the disk space that is capableof filling the entire debrided area in an efficient and safe fashion.This should allow for maximization of arthrodesis potential, increasepatient safety, and decrease operative time.

Referring now to FIGS. 75A to 75F, an embodiment of an integrated fusioncage and graft delivery device 1 of the present disclosure isillustrated. The graft delivery device generally includes a cannular orhollow tube 2, a plunger 12, and a detachable funnel 30.

The hollow tube 2 is the same as, or similar to, other embodiments ofhollow tubes described herein. Accordingly, the hollow tube 2 generallyincludes an opening 4 at a proximal end 6. At least one dischargeopening 7 is associated with a distal end 8 of the hollow tube. In oneembodiment, the discharge opening 7 is positioned transverse to alongitudinal axis of the hollow tube 2. Accordingly, in one embodiment,the distal end 8 is at least partially closed opposite to the proximalopening 4. Alternatively, the distal end 8 may be completely closed.Optionally, a discharge opening 7 may be formed through at least aportion of the distal end. Specifically, in one embodiment, the hollowtube 2 can include a discharge opening 7 aligned with a longitudinalaxis of the hollow tube.

In one embodiment, the distal end 8 is rounded or smooth with awedge-shape 50. Specifically, the distal end can have a shape configuredto facilitate easy entry into a disc space. In this manner, the shape ofthe distal end minimizes soft tissue damage or irritation. Thewedge-shape 50 enables insertion of the distal end 8 into a collapseddisc space without damaging the endplates or skating off to anunintended location. In contrast, some prior art devices with an opendistal end can injure bony end plates of the disc space of a patient.

Optionally, the hollow tube includes two discharge openings 7A, 7B. Thetwo discharge openings 7 can be arranged on opposite sides of the hollowtube to eject graft material. Accordingly, in one embodiment, the hollowtube 2 is operable to dispense bone graft material laterally away from alongitudinal axis of the graft delivery device 1. In one embodiment, thetwo discharge openings 7 are of substantially the same size and shape.The discharge openings 7 may have a generally oval shape.

In another embodiment, at least one opening 7C (illustrated in FIG. 75D)is formed in the distal end 8. Thus, the graft delivery device 1 maydischarge bone graft material through the distal end 8 in line with thelongitudinal axis of the graft delivery device 1. The opening 7C mayhave any predetermined shape. Optionally, the opening 7C has arectangular, round, or ovoid shape. The distal end 8 may optionallyinclude a taper or wedge shape 50 with an end opening 7C formedtherethrough.

The hollow tube 2 is substantial hollow between the proximal end and thedistal end. Specifically, a lumen 28 extends through the hollow tube 2.The lumen 28 has a predetermined cross-sectional shape. In oneembodiment, the cross-sectional shape of the lumen is one of round,ovoid, square, rectangular, and approximately rectangular with roundedcorners or edges. In another embodiment, the interior of the lumen isnot round and is, for example, rectangular. Optionally, thecross-sectional shape of the lumen 28 is substantially uniform along thelength of the hollow tube 2. In one embodiment, the lumen 28 has auniform cross-sectional size along its length. The exterior of thehollow tube 2 may have a shape that is one of round, ovoid, square, andrectangular.

A ramp 9 may be formed within the hollow tube proximate to the opening7. As described herein, the ramp 9 includes surfaces configured todirect the bone graft material away from the opening 7 into a surgicalsite, such as a disc space. More specifically, the ramp 9 functions as areverse funnel to disperse bone graft material ejected from the opening7 as generally illustrated in FIG. 77A.

In one embodiment, surfaces of the ramp 9 are linear in shape, that is,forming a triangle in cross-section. In another configuration, surfacesof the ramp 9 are of any shape that urges egress of bone graft materialcontained in the hollow tube to exit the lumen 28 of the hollow tube 2through the at least one opening 7 of the device 1.

The hollow tube 2 is configured to receive the plunger 12 of the presentdisclosure within the lumen 28. Any plunger 12 of the present disclosuremay be used with the hollow tube 2. The plunger 12 can be used to pushbone graft material positioned in the lumen 28 out of the opening 7 atthe distal end 8. Optionally, a stop 16A can be formed on the plunger 12to engage the proximal end 6 of the hollow tube. In this manner, thestop 16A prevents over insertion of the plunger within the lumen.

Optionally, the plunger 12 may include a plurality of teeth separated bynotches 27. The notches 27 can be engaged by a means for advancing bonegraft material described herein. In one embodiment, the means foradvancing comprises a ratchet configured to engage the notches 27. Inoperation, the ratchet can engage successive notches to advance orwithdraw the plunger within the hollow tube.

Additionally, or alternatively, the means for advancing can include agear with teeth. The gear is aligned with the plunger and operable toconvert rotational movement of the rear to linear movement of theplunger. As the gear rotates, the gear teeth engage the plunger notches27 to move the plunger toward or away from the hollow tube distal end.

In still another embodiment, the means for advancing comprises a wormgear with at least one helical thread. As the worm gear rotates, thehelical thread engages the plunger notches 27. In this manner, the wormgear can advance or retract the plunger within the hollow tube.

The plunger 12 includes a distal end 18. The distal end 18 substantiallyconforms to inner walls of the lumen 28. Specifically, in oneembodiment, the distal end 18 has a cross-sectional shape whichcorresponds to the interior shape of the lumen 28. Optionally, theplunger distal end 18 is round, ovoid, square, or rectangular. In oneembodiment, the distal end 18 is not round. In another embodiment, theplunger distal end is configured to contact the inner walls of the lumen28 about an entire outer periphery of the plunger distal end.Additionally, or alternatively, the plunger 12 (or a portion of theplunger 12) may be made of rubber silicone to improve the seal withinterior surfaces of the lumen 28. In some embodiments, at least thedistal end 18 is made of a plastic or an elastomeric rubber.

In one embodiment, the plunger has a length sufficient for the distalend 18 of the plunger to extend beyond the opening 7 as generallyillustrated in FIG. 75C. In one embodiment, the handle 16 of plunger isa planar disk shape, as depicted in FIG. 75C. In another embodiment,handle 16 is not planar. For example, handle 16 is angled so as toconform to interior of funnel 30 when the plunger 12 is fully insertedinto hollow tube 2.

Notably at least one vent port 21 may be formed through the hollow tube2 to the lumen 28. The vent port 21 is configured to release air fromthe interior of the hollow tube 2 as bone graft material is delivered tothe distal end 8 for discharge out of the opening 7. As one of skill inthe art will appreciate, air trapped within the lumen 28 of the hollowtube 2 between the distal end 8 and bone graft material may increase theamount of axial force required by the plunger 12 to move the bone graftmaterial to the discharge opening 7 or may cause the plunger to jam orbind in the lumen. Applying excessive force to the plunger to eject thebone graft material can cause soft tissue inflammation or damage. Byallowing air to escape from within the lumen 28 of the hollow tube 2 asthe plunger 12 is pressed toward the distal end 8, the vent port 21 maydecrease the amount of force required to deliver the bone graft materialto the discharge opening 7. The possibility of the plunger 12 jammingwithin the hollow tube 2 is also reduced. Specifically, the vent port 21eliminates or reduces the risk of jamming the plunger and also reducesthe possibility of trapped air being forced into the disc space and intothe patient's vascular system causing an air embolism.

The vent ports 21 also prevent introduction of air or other fluids intothe surgical site. For example, air may be introduced into, and trappedwithin, bone graft material as the bone graft material is loaded intothe hollow tube. As the plunger presses against the bone graft material,the air may be released from the bone graft material. The air can escapefrom the lumen 28 through the vent ports 21.

Vent ports 21 can be formed through the hollow tubes 2 of allembodiments of the present disclosure. Vent ports 21 may be formed atany location of the hollow tube 2 along the length of the hollow tubebetween to proximal end 6 and the distal end 8. Optionally, a vent port21 is formed on at least one of the first surface 3 and the secondsurface 5. In one embodiment, vent ports 21 can be formed on more thanone surface 3, 5 of the hollow tube.

The at least one vent port 21 is configured to prevent discharge of bonegraft material from the lumen 28. Accordingly, the vent port 21 has oneor more of a size and a shape selected to prevent passage of bone graftmaterial therethrough. In one embodiment, a width or a diameter of thevent port is less than approximately 2 mm. Optionally, the vent port 21includes a mesh or screen with apertures which allow passage of airtherethrough.

As illustrated in FIG. 75B, the vent port 21 can optionally have agenerally circular shape, such as a bore. Although the vent port 21illustrated in FIG. 75B is generally circular, other shapes arecontemplated. In one embodiment, the vent port is a slit or slot. Theslot may be generally linear. In another embodiment, the vent port 21has a shape that is generally triangular or rectangular. Specifically,the vent port 21 may have any size or shape which allows the passage ofair but prevents passage of bone graft material therethrough.

Any number of vent ports 21 may be formed through the hollow tube 2. Inone embodiment, the hollow tube 2 includes at least three vent ports 21.A first vent port 21A can be proximate to the proximal end 6 of thehollow tube 2. A second vent port 21B can be proximate to the distal end8. A third vent port 21C can be formed between the first and second ventports 21A, 21B.

Additionally, or alternatively, in another embodiment, the plunger 17includes a channel 35 (such as generally illustrated in FIG. 75A)configured to release air from the distal end 8 of the lumen 28 to theproximal end of the lumen. In this manner, as the plunger is advanced toeject bone graft material from the discharge opening 7, air trapped inthe bone graft material and/or the lumen distal end 8 (the portion ofthe lumen distal to the distal end 18 of the plunger 12) can passthrough the channel 35 into the proximal portion of the lumen.

Optionally, indicia 29 may be formed on one or more surface of thehollow tube 2. The indicia are configured to indicate a depth ofinsertion of the distal end 8 of the hollow tube into a surgical site.The indicia 29 can include marking and numerals. Optionally, one or moreof the indicia 29 may be radiopaque. The indicia 29 may extend along thelength of the hollow tube, or a predetermined portion of the length.

In one embodiment, the hollow tube 2 may comprise a first portion 22 anda second portion 23 which are configured to be interconnected. Thehollow tube 2 thus includes a joint 24, illustrated in FIG. 75C, alongwhich the first and second portions 22, 23 are connected. The joint 24may substantially bisect the hollow tube 2.

The first and second portions 22, 23 can be interconnected by anysuitable means. In one preferred embodiment, an ultraviolet activatedadhesive is used to interconnect the first and second portions 22, 23.This forms a particularly strong bond in combination with optionalalignment features 25, 26 (best seen in FIG. 75E) and the material ofthe hollow tube 2.

In another embodiment, the first and second portions 22, 23 aresonically welded together. Additionally, or alternatively, other gluesor adhesives can be used to join the first and second portions 22, 23.

Optionally, the first and second portions can include the alignmentfeatures 25, 26. In addition to ensuring alignment of the first portion22 with respect to the second portion 23 when the hollow tube 2 isassembled, the alignment features 25, 26 can also provide support to thehollow tube 2. In one embodiment, the alignment features 25, 26 have ashape selected to increase rigidity of the hollow tube 2, such as toprevent unintended or inadvertent bending or movement.

The alignment features 25, 26 may comprise a projection 25 formed on oneof the first and second portions 22, 23 that is at least partiallyreceived in a bore or aperture 26 of another of the first and secondportions 22, 23. In one embodiment, the alignment feature 25 comprises apeg or pin. Optionally, alignment feature 26 comprises a recessconfigured to receive the peg 25. In one embodiment, one of thealignment features 25, 26 comprises a flange. The flange may extendalong some or all of the joint 24. The other one of the alignmentfeatures 26, 25 may comprise a groove configured to receive the flange.Similar to the flange, the groove may extend along some or all of thejoint 24. Other shapes and features of the alignment features 25, 26 arecontemplated.

The alignment features 25, 26 can also be configured to lock the firstand second portion 22, 23 together. Specifically, in one embodiment,alignment feature 25 comprises a projection configured to engage acorresponding recess in alignment feature 26. Feature 26 canfrictionally engage feature 25.

The hollow tube 2 may be made of a flexible, semi-rigid, or rigidmaterial including one or more of a plastic, a composite, a metal. Inone embodiment, the hollow tube 2 is formed of polycarbonate resinthermoplastic. Optionally, at least a portion of the hollow tube 2 isradiopaque. In one embodiment, at least the distal end 8 is radiopaqueor includes radiopaque markers, such as indicia 29.

In one embodiment, the hollow tube 2 is substantially rigid. Optionally,at least a portion of the hollow tube 2 may be flexible. For example, inone embodiment, at least about one-half of the hollow tube 2 comprisingthe distal end 8 is flexible.

In one embodiment, the hollow tube 2 is generally linear. Alternatively,the hollow tube 2 can include a portion that is not linear. Morespecifically, in one embodiment, the hollow tube 2 can have a permanent(or temporary) curve or bend.

Alternatively, in another embodiment, the proximal end 6 of the hollowtube can extend along a first longitudinal axis. At least the distal end8 of the hollow tube 2 may extend along a second longitudinal axis thatis transverse to the first longitudinal axis of the proximal end. Thedistal end 8 can extend at a predetermined angle from the proximal end6. Optionally, the angle can be between about 0° and about 75°. In oneembodiment, the distal end 8 intersects the proximal end 6 at a joint.The joint may be adjustable such that a user can alter the angle betweenthe proximal end and the distal end. Alternatively, the joint is notadjustable. The proximal end and the distal end may each extendgenerally linearly to the joint. Alternatively, the hollow tube 2 mayinclude a transition portion between the proximal end and the distalend. The transition portion can have a shape that is curved, such as anelbow joint.

The hollow tube 2 may be made of a substantially transparent ortranslucent material. Accordingly, in one embodiment, the hollow tube isnot opaque. Optionally, at least a portion of the hollow tube 2 istransparent or translucent. In one embodiment, the hollow tube 2 iscomprised of a transparent or translucent material, or includes windowsof a transparent or translucent material. Accordingly, in embodiments,the plunger 12 is at least partially visible within the lumen 28.

Referring now to FIG. 75D, one or more of an endoscope, camera, andimage sensing device 36 can optionally be associated with the hollowtube 2. More specifically, in one embodiment, one or more of anendoscope and a camera or image sensor can be coupled to the hollowtube. The endoscope, camera, or image sensor 36 can be removably orpermanently coupled to the hollow tube. In one embodiment, theendoscope, camera, or image sensor 36 can extend through a portion ofthe hollow tube 2. In another embodiment, the endoscope, camera, orimage sensor are interconnected to an exterior surface of the hollowtube 2. Additionally, or alternatively, the endoscope, camera, or imagesensor may extend within at least a portion of the lumen 28.

The endoscope, camera, or image sensing device 36 may be oriented toview at least the distal end 8. Optionally, the endoscope, camera, orimage sensing device 36 is repositionable with respect to this distalend. In this manner, the endoscope, camera, or image sensing device 36can be manipulated to view one or more openings 7 of the hollow tube 2,or view the internal aspect of the disc space 172A, or a debridedportion of the disc space 172A, prior to administration of bone graft.

Also, in another embodiment, the hollow tube 2 can include lightingelements 37. The lighting elements may be associated with the optionalendoscope, camera, or image sensor 36. Additionally, or alternatively,one or more lighting elements 37 can be fixed to, or integrally formedwith, the hollow tube 2. Suitable lighting elements, cameras, anddisplays that may be used with the integrated fusion cage and graftdelivery device 1 of the present disclosure are described in U.S. Pat.Nos. 8,864,654, 9,717,403, and PCT Pub. WO 2012/145048 which are eachincorporated herein by reference in their entirety.

As illustrated in FIGS. 75B and 75C, the funnel 30 can be releasablyinterconnected to the hollow tube. The funnel facilitates loading ofbone graft material into the opening 4 at the proximal end 6 of thehollow tube 2. Once the lumen 28 is loaded with bone graft material, thefunnel may be removed to improve visualization of the distal end 8 andopening 7 in a surgical site, such as a disc space. In contrast to priordevices which include a fixed funnel which cannot be removed, thereleasable funnel 30 of the present disclosure does not obstructvisualizing the distal end 8 of the hollow tube 2 as it is placed in adisc space or other surgical site. Optionally, if additional bone graftmaterial is required, the funnel 30 may be interconnected to the hollowtube during the surgical procedure without having to remove the hollowtube 2 from the surgical site, resulting in decreased potential traumato adjacent nerve tissue.

In one embodiment, the funnel 30 is retained on the hollow tube 2 by afriction fit. Alternatively, the funnel can snap onto the hollow tube.Optionally, in one embodiment, the hollow tube 2 include a collar 106Awith one or more projection 106B. The funnel 30 has a sleeve 32 thatfits over the collar 106A and engages the projection 106B. Optionally,the sleeve 32 includes a slot 33 to engage the projection 106B. The slot33 and projection 106B form a bayonet mount. In this manner, funnel canbe releasably interconnected to the hollow tube.

Optionally, the hollow tube 2 can be configured to receive a fusion cage60 of one or more of the embodiments described herein. Optionally, thefusion cage 60 may have a fixed height. Alternatively, the fusion cagemay be expandable after placement in a disc space.

In one embodiment, the fusion cage includes an opening 65 to dischargebone graft material therethrough. The opening 65 is alignable with theopening 7 of the hollow tube. Optionally, the fusion cage 60 may includetwo or more openings 65 which each correspond to openings 7A, 7B of thehollow tube. Accordingly, as bone graft material is advanced through thelumen and through the opening 7 of the hollow tube, the bone graftmaterial will be discharged through opening 65 of the fusion cage into asurgical site, such as a disc space.

In one embodiment, a distal end 64 of the fusion cage is closed. Thedistal end 64 may have a blunt or tapered shape similar to the wedgeshaped end 50 of the hollow tube.

In one embodiment of the device 1, the width of the hollow tube secondexterior surface 5 is between 9 and 15 mm. In a preferred embodiment,the width of the hollow tube second exterior surface 5 is between 11 and13 mm. In another embodiment, the width of the hollow tube secondexterior surface 5 is between 11.5 mm and 12.5 mm. In yet anotherembodiment, the width of the hollow tube second exterior surface 5 is 12mm.

In one embodiment of the device 1, the width of the hollow tube firstexterior surface 3 is between 5 and 11 mm. In another embodiment, thewidth of the hollow tube first exterior surface 3 is between 7 and 9 mm.Optionally, the width of the hollow tube first exterior surface 3 isbetween 7.5 mm and 8.5 mm. In one embodiment, the width of the hollowtube first exterior surface 3 is 8 mm.

In one embodiment of the device, the ratio of the width of the hollowtube second exterior surface 5 and the width of the hollow tube firstexterior surface 3 is between approximately 1.7 and 1.3. In anotherembodiment, the ratio of the width of the hollow tube second exteriorsurface 5 and the width of the hollow tube first exterior surface 3 isbetween 1.6 and 1.4. In still another embodiment, the ratio of the widthof the hollow tube second exterior surface 5 and the width of the hollowtube first exterior surface 3 is between 1.55 and 1.45. In oneembodiment, the ratio of the width of the hollow tube second exteriorsurface 5 and the width of the hollow tube first exterior surface 3 is1.5.

In one embodiment of the device, the width of the interior of the hollowtube major axis (located adjacent the second exterior surface 5) isbetween 9 and 13 mm. In another embodiment, the width of the interior ofthe hollow tube major axis is between 10 and 12 mm. Optionally, thewidth of the interior of the hollow tube major axis is between 10.5 mmand 11.5 mm. In one embodiment, the width of the interior of the hollowtube major axis is 11 mm.

In one embodiment of the device 1, the width of the interior of thehollow tube minor axis (located adjacent the first exterior surface 3)is between 5 and 9 mm. In another embodiment, the width of the interiorof the hollow tube minor axis is between 6 and 8 mm. In yet anotherembodiment, the width of the interior of the hollow tube minor axis isbetween 6.5 mm and 7.5 mm. In one embodiment, the width of the interiorof the hollow tube minor axis is 7 mm.

In one embodiment of the device 1, the ratio of the width of theinterior of the hollow tube major axis and the width of the interior ofthe hollow tube minor axis is between approximately 1.7 and 1.3. Inanother embodiment, the ratio of the width of the interior of the hollowtube major axis and the width of the interior of the hollow tube minoraxis is between 1.6 and 1.4. Optionally, the ratio of the width of theinterior of the hollow tube major axis and the width of the interior ofthe hollow tube minor axis is between 1.55 and 1.45. In one embodiment,the ratio of the width of the interior of the hollow tube major axis andthe width of the interior of the hollow tube minor axis is 1.5.

In one embodiment, one or more edges of the device are rounded. Forexample, the exterior edges of the hollow tube are rounded, and/or theinterior edges of the hollow tube are rounded (in which case the edgesof the plunger, at least at the plunger distal end, are identicallyrounded to ensure a congruous or conformal fit between the edges of theplunger and the interior of the hollow tube so as to, among otherthings, urge the majority of bone graft material to move through thehollow tube).

The device 1 may optionally be printed using a three-dimensionalprinting process. More specifically, one or more of the hollow tube 2,the plunger 12, the funnel 30, and the fusion cage 60 may bemanufactured by one or more three-dimensional printing processes. Avariety of materials, including a metal, PEEK, and other plastics may beused in a three-dimensional printer to form the device 1.

Referring now to FIG. 75F, devices 42 for preparing a bone graftmaterial 44 according to one embodiment of the present disclosure areillustrated. Specifically, in one embodiment, bone graft material 44 isprepared within one or more devices 42, such as graduated syringes. Thebone graft material 44 is compressed or compacted to form a desired andmeasured amount of bone graft material. Optionally, the bone graftmaterial comprises two or more components 44A, 44B. A first one of thecomponents 44A, 44B may be an activating agent or a liquid. A second oneof the components 44A, 44B may be a dry material or a granular material.

The bone graft components 44A, 44B may be mixed together byinterconnecting the devices 42A, 42B. Optionally, the devices 42A, 42Bmay be interconnected with a bayonet mount. In one embodiment, aconnecting device 46 is provided to interconnect device 42B to device42A. Connecting device 46 may include luer locks. The luer locks mayinclude a locking or slip style connector. A bore 48 through theconnecting device 46 enables bone graft material to be injected from onesyringe to the other syringe 42. In one embodiment, component 44B isinjected from device 42B into device 42A to be mixed with bone graftcomponent 44A.

The mixed bone graft material 44A, 44B can subsequently be dischargedfrom device 42A into the hollow tube 2. In one embodiment, the device42A can be interconnected to the proximal end 6 of the hollow tube 2.Additionally, or alternatively, the bone graft material 44 can beejected from the device 42A into the funnel 30. Suitable devices 42 thatcan be used to prepare bone graft material for use with the integratedfusion cage and graft deliver device 1 of the present disclosure areknown and described in U.S. Pat. Pub. 2009/0124980, U.S. Pat. Pub.2014/0088712, U.S. Pat. Pub. 2014/0276581, U.S. Pat. Pub. 2014/0371721,U.S. Pat. Nos. 8,439,929, and 9,174,147 which are each incorporatedherein by reference in their entirety.

The integrated fusion cage and graft deliver device 1 of the presentinvention provides many benefits over other devices. For example, therectangular or approximately rectangular lumen 28 of embodiments of thehollow tube 2 affords several advantages over conventional circularconfigurations. For a surgical area with a smallest dimension set at awidth of 8 mm and a thickness dimension 0.5 mm, a conventional circulardevice (with resulting interior diameter of 7 mm or a radius of 3.5 mm)would realize a surface area of 38.48 mm² Applicants' device would carryinterior dimension of 7 mm by 11 mm for a surface area of 77 mm², anincreased surface area factor of 2.0, thereby resulting in more bonegraft material delivery, because, among other things, a given volume ofbone graft encounters less surface area of the interior of a particulardevice which results in, among other things, reduced chance of jammingof bone graft material within the device.

Referring now to FIG. 76, a cross-sectional view of a bone graftdelivery device 170 provided in combination with a surgical work site172 is illustrated. Specifically, a bone graft delivery device 170 isshown as providing a bone graft material 44 to an intervertebral space172 within a human spine. The tool 170 is generally inserted into apatient from a transforaminal or lateral access site, and a second endof the delivery device 170 is provided within the intervertebral spaceto which bone graft material 44 is to be provided. The device 170includes a conventional end-dispensing lumen that ejects and injects thebone graft material 44 directly into the intended path of a fusion cage.The device and method of FIG. 76 does not distribute bone graft deliverymaterial into the periphery of the prepared disc space and generallyfails to achieve appropriate distribution of bone graft deliverymaterial within the disc space 172. Additionally, the small diametertube necessitates injecting the bone graft material 44 in a more liquid(less viscous) state. In some cases, the pressure required to push bonegraft material through the bore of device 170 is relatively high,increasing the risk of the device jamming. Generally, the risk of injuryto the patient increases as the pressure required to eject the bonegraft material from the delivery device 170 increases. Furthermore, ifthe device jams, then it needs to be removed, increasing the cumulativetrauma to the surrounding nerve tissue as the device is removed andreinserted.

Referring now to FIG. 77A, an integrated fusion cage and graft deliverdevice 1 according to embodiments of the present disclosure isillustrated delivering bone graft material 44 to a disc space 172 withina patient's spine 171. As shown, the hollow tube 2 of the device 1 isprovided with at least one opening 7. Bone graft material 44 is providedto the intervertebral space 172 by ejecting the material from theopening 7. In some embodiments, the hollow tube 2 has two openings suchthat bone graft material 44 is ejected on opposing sides of the device1. In this manner, the device 1 provides enhanced distribution of bonegraft material 44 and a greater quantity of bone graft material into asurgical site compared to the device 170 described in conjunction withFIG. 76. Further, the larger cross-sectional shape of the hollow tube 2of the deliver tool 1 of the present invention allows injection of bonegraft material in a thicker, more controllable viscous state and withless force than required by device 170.

An additional benefit of some embodiments of devices 1 of the presentdisclosure is that they avoid injection of bone graft material 44directly into the path or intended path of a cage, such as illustratedin FIG. 76. For example, FIG. 77B provides a top view of the surgicalworkspace 172 according to FIG. 77A, after the integrated fusion cageand graft deliver device 1 has been removed after insertion or injectionof the bone graft material 44. As shown in FIG. 77B, removal of the bonegraft delivery tool provides an unobstructed path 174 and void space forsubsequent insertion of a fusion cage (not shown in FIG. 77B). In thismanner, devices 1 of the present disclosure provide for a sufficientamount of bone graft material within the surgical site 172 and providean area 174 that is operable to receive a fusion cage.

Referring now to FIG. 78, another embodiment of an integrated fusioncage and graft delivery device 1 of the present disclosure isillustrated. The integrated device 1 generally includes a hollow tube 2,a fusion cage 60, and a means for advancing bone graft material throughthe hollow tube. The means for advancing may use manual force,mechanical force, electric force, pneumatic force, or any other force toadvance bone graft material through the hollow tube. In one embodiment,a user can manipulate the integrated device 1 with a single hand. Thisbeneficially frees the user's other hand for other action.

In one embodiment, the means for advancing includes a handle or grip304. The grip 304 is operable to selectively move bone graft materialthrough the lumen of the hollow tube 2 for discharge from an opening 7at the tube distal end 8.

The hollow tube 2 includes a proximal end 6 configured to releasablyinterconnect to the grip 304. Bone graft material can be positionedwithin the lumen of the hollow tube 2, such as with a funnel 30(illustrated in FIG. 75B). The funnel 30 may then be removed from theproximal end 6. The proximal end 6 can then be interconnected to thegrip 304. Optionally, the hollow tube 2 can be used to eject bone graftmaterial into a surgical site without being affixed to the grip.

The grip 304 can frictionally engage the tube proximal end 6. In oneembodiment, the hollow tube 2 or the grip 304 include a lock or a latchto secure the hollow tube 2 to the grip. In another embodiment, aportion of the hollow tube 2 can threadably engage the grip 304. Inanother embodiment, the proximal end 6 and grip 304 are interconnectedwith a bayonet mount. Additionally, or alternatively, the grip 304 canoptionally include a knob 310 such that the hollow tube 2 can beselectively interconnected to the grip 304. Other means ofinterconnecting the hollow tube 2 to the grip 304 are contemplated.

A channel 324 is formed through the grip 304. The channel 324 includes aproximal opening 326 and extends through the grip 304 and the knob 310.In one embodiment, the opening 326 is configured to receive a plunger12. The plunger 12 can extend through the channel 324 into a hollow tube2 interconnected to the grip 304.

The grip 304 includes a means for advancing bone graft material throughthe lumen of the hollow tube 2. In one embodiment, the means foradvancing comprises a compressed fluid. Specifically, in one embodiment,the grip 304 is configured to advance the bone graft material using thecompressed fluid, such as air. Manipulating the grip trigger 306 canrelease compressed fluid into the proximal end 6 of the lumen. In oneembodiment, the hollow tube includes a single vent port 21B at thedistal end. When a proximal end of bone graft material within the lumenreaches the vent port 21B, the compressed fluid is released from thelumen. In this manner, the fluid is not introduced into the surgicalsite.

Optionally, a pusher 18A may be positioned in the lumen of the hollowtube 2 after the lumen is loaded with bone graft material. The pusher18A may be similar to the distal end 18 of a plunger 12, such asgenerally illustrated in FIG. 75A. Regardless, the pusher 18A isconfigured to substantially conform to interior surfaces of the lumen.In this manner, the pusher 18A prevents the fluid from being dischargedfrom the opening 7 into the surgical site.

When a pressurized fluid is introduced into the lumen behind the pusher18A, the pusher advances toward the distal end 8. The bone graftmaterial is urged toward the distal end 8 and through the opening 7 bythe pusher. In one embodiment, when a proximal end of the pusher 18Aadvances past the vent port 21B, the compressed fluid is released fromthe lumen and the pusher stops. Alternatively, the pusher may stopadvancing by contact with an interior ramp 9 within the hollow tube 2.

In another embodiment, the means for advancing the bone graft materialcomprises a plunger 12. Accordingly, in one embodiment, the grip 304 isconfigured to selectively advance a plunger 12 through the lumen toadvance the bone graft material. The grip 304 is configured to advancethe plunger 12 axially with respect to the lumen of the hollow tube 2.Specifically, the grip can manipulate the plunger 12 such that a distalend of the plunger opposite the plunger handle 16 moves towards thedistal end 8 of the hollow tube 2. The grip 304 is configured tomanually or automatically apply a force to the plunger 12. The force canbe generated by one or more of a user, a motor, a compressed fluid, orany other means of generating a force.

In one embodiment, the plunger 12 includes teeth, notches 27, ordepressions which are engageable by the grip 304 to axially adjust theposition of the plunger 12. The notches can be substantially evenlyspaced along the plunger.

In one embodiment, a motor is positioned within the grip 304 to advancethe plunger. Optionally, the motor is operable to rotate a shaft. Theshaft may include a gear to translate the rotational movement into alinear movement of the plunger 12. In one embodiment, the gear includesteeth to engage the notches 27 or teeth of the plunger 12. A battery canprovide power to the motor. In one embodiment, the battery is housed inthe grip 304.

Optionally, the grip includes a gear or a ratchet configured to engageteeth, notches 27, or depressions on the plunger 12. Specifically, inone embodiment, the ratchet of the grip 304 is configured to engage theplurality of notches 27 formed in the plunger. In one embodiment, thechannel 324 of the grip 304 includes an aperture or window through whicha portion of the gear or ratchet can extend to engage the plunger 12.

In one embodiment, when activated, the ratchet engages a first notch andthen a second notch to incrementally advance the plunger distally withinthe hollow tube 2. Bone graft material within the hollow tube 2 is thenpushed by the plunger 12 toward the distal end 8 of the hollow tube.Ratcheting mechanisms that can be used with the grip 304 are known tothose of skill in the art. Some examples of ratcheting mechanisms aredescribed in U.S. Pat. App. Pub. 2002/0049448, U.S. Pat. App. Pub.2004/0215201, U.S. Pat. App. Pub. 2009/0264892, U.S. Pat. Nos.7,014,640, 8,932,295, 9,655,748, and 9,668,881 which are eachincorporated herein by reference in their entirety.

Optionally, the grip 304 can be configured to discharge a predeterminedamount of bone graft material each time the plunger 12 is incrementallyadvanced within the hollow tube. In one embodiment, between about 0.25and 1.0 cc of bone graft material is discharged from the distal end 8 ofthe hollow tube 2 each time the plunger is advanced. In anotherembodiment, between about 0.25 and 1.0 cc of bone graft material isdischarged is discharged each time the trigger 306 is actuated by auser.

The grip 304 can optionally be configured to enable vision of a surgicalsight by a user. Specifically, the grip 304 may be substantially evenwith one or more surfaces 3, 5 of the hollow tube. In this manner, inone embodiment, the grip 304 does not obstruction a line of sight alongat least one surface 3, 5. In another embodiment, an exterior surface ofthe grip is about even with a plane defined by one of the side surfaces3. Additionally, or alternatively, an upper portion of the grip does notextend beyond a plane defined by a top surface 5 of the hollow tube.Optionally, a window or view port is formed in the grip 304 to allowview of the distal end 8 of the hollow tube 2.

Additionally, or alternatively, a visualization system is associatedwith the hollow tube. In one embodiment, the visualization systemincludes (but is not limited to) one or more of a camera, a light, anendoscope, and a display. The visualization system may be permanently orremovably affixed to the integrated fusion cage and graft deliverydevice 1.

In one embodiment, the grip 304 includes a motor or other actuator whichcan be manipulated by a user to advance or withdraw the plunger in thehollow tube 2. The motor or actuator can operate the ratchet.

Optionally, the grip 304 is manually manipulated by a user to move theplunger 12. In one embodiment, the grip 304 includes a trigger 306. Thetrigger 306 may be hinged or pivotally interconnected to the grip 304.When the trigger 306 is actuated by a user, the plunger 12 is advancedin the hollow tube 2.

Actuating the trigger 306 may include pulling the trigger toward ahandle 308 of the grip. The trigger 306 can be biased away from thehandle 308 as generally illustrated in FIG. 10. Pulling the trigger 306toward the handle 308 causes the ratchet to engage the plunger 12. Theratchet engages a notch 27 of the plunger 12 and moves the plungertoward the distal end 8 of the hollow tube. Successively pulling thetrigger 306 incrementally advances the plunger 12 forward in the hollowtube.

In one embodiment, the ratchet is associated with an upper end of thetrigger 306. In this embodiment, pulling the trigger 306 causes theratchet to move toward the hollow tube 2. Optionally, a lock pawl (notillustrated) can be associated with the grip 304. The lock pawl canengage a notch of the plunger 12 to prevent inadvertent movement of theplunger distally.

The grip 304 can be used to advance or withdraw the plunger 12.

Optionally, the grip 304 includes a switch 312 operable to change thedirection of movement of the plunger 12. By manipulating the switch 312,a user can cause the plunger 12 to advance into the hollow tube 2 or,alternatively, withdraw from the hollow tube. In one embodiment, towithdraw the plunger 12, the plunger handle 16 can be pulled away fromthe grip 304. The switch 312 may comprise a button.

The grip 304 can optionally include a loading port 314. The loading port314 provides access to the lumen of the hollow tube 2. In oneembodiment, the loading port 314 is in fluid communication with thechannel 324 through the grip 304. Accordingly, bone graft material canbe added to the hollow tube through the loading port 314. In oneembodiment, the loading port 314 is configured to engage a funnel 30 ofany embodiment of the present disclosure. Additionally, oralternatively, a syringe 42 may interconnect to the grip 304 todischarge bone graft material 42 into the lumen through the loadingport.

Additionally, or alternatively, a capsule or package 316 of bone graftmaterial can be loaded into the lumen through the loading port 314. Thepackage 316 can include any type of bone graft material, including oneor more of: autogenous (harvested from the patient's own body),allogeneic (harvested from another person), and synthetic. Apredetermined amount of bone graft material can be included in thepackage 316. In one embodiment, each package includes between about 0.25and 1.0 cc of bone graft material. One or more packages 316 may beloaded into the lumen to deliver a desired amount of bone graft materialto a surgical site.

Referring now to FIG. 79, still another embodiment of an integratedfusion cage and graft delivery device 1 of the present disclosure isillustrated. The device 1 illustrated in FIG. 79 is similar to thedevice 1 described in conjunction with FIG. 78 and includes many of thesame, or similar features. The integrated device 1 generally includes ahollow tube 2 configured to receive a fusion cage 60 and a means foradvancing bone graft material through the hollow tube for discharge outof an opening 65 of the fusion cage.

In one embodiment, the means for advancing includes a grip 304. The grip304 is configured to interconnect to a hollow tube 2 of any embodimentof the present disclosure. The grip 304 is operable to selectively movebone graft material through the lumen of the hollow tube 2 for dischargefrom the tube distal end 8. Bone graft material can be positioned withinthe lumen while the hollow tube 2 is interconnected to the grip 304.

The grip 304 can frictionally engage a predetermined portion of thehollow tube 2. In one embodiment, the hollow tube 2 or the grip 304include a lock or a latch to secure the hollow tube 2 to the grip.Optionally, the grip 304 engages at least the two side surfaces 3 of thehollow tube 2. In one embodiment, the grip 304 includes opposing flanges320. One or more of the flanges 320 can be moved inwardly toward thehollow tube similar to a clamp. In this manner, the flanges 320 canapply a compressive force to the side surfaces 3 to interconnect thehollow tube 2 to the grip. Other means of interconnecting the hollowtube 2 to the grip 304 are contemplated.

The grip 304 includes a means for advancing bone graft material throughthe lumen of the hollow tube 2. In one embodiment, the means foradvancing comprises a compressed fluid. Specifically, in one embodiment,the grip 304 is configured to advance the bone graft material using thecompressed fluid, such as air. Manipulating the grip trigger 306 canrelease compressed fluid into the proximal end 6 of the lumen. When apressurized fluid is introduced into the lumen, the plunger advancestoward the distal end 8. The bone graft material is urged toward thedistal end 8 and through the opening 65 by the plunger 12. In oneembodiment, the plunger may stop advancing by contact with an interiorramp within the hollow tube 2.

In another embodiment, the means for advancing the bone graft materialis configured to selectively advance the plunger 12 through the lumen toadvance the bone graft material. Specifically, the grip 304 isconfigured to manually or automatically apply a force to the plunger 12.The force can be generated by one or more of a user, a motor, acompressed fluid, or any other means of generating a force.

In one embodiment, a motor is positioned within the grip 304 to advancethe plunger. Optionally, the motor is operable to rotate a shaft. Theshaft may include a gear to translate the rotational movement of theshaft into a linear movement of the plunger 12. In one embodiment, theplunger includes notches to engage the gear of the shaft. A battery canprovide power to the motor. In one embodiment, the battery is housed inthe grip 304.

In one embodiment, the plunger 12 includes teeth, notches, ordepressions which are engageable by the grip 304 to axially adjust theposition of the plunger 12. Optionally, the grip includes a gear or aratchet configured to engage teeth or notches on the plunger 12.

Specifically, in one embodiment, the ratchet of the grip 304 isconfigured to engage a plurality of notches formed in the plunger. Thenotches can be substantially evenly spaced along the plunger. Theratchet engages a first notch and then a second notch to incrementallyadvance the plunger distally within the hollow tube 2. Bone graftmaterial within the hollow tube 2 is then pushed by the plunger 12toward the distal end 8 of the hollow tube.

The grip 304 is configured to enable vision of a surgical sight by auser. Specifically, in one embodiment, the grip 304 does not extendabove a top surface 5 of the hollow tube. In this manner, in oneembodiment, the grip 304 does not obstruction a line of sight along atleast the top surface 5. In another embodiment, lateral surfaces of thegrip are about even with a plane defined by one of the side surfaces 3of the hollow tube.

In one embodiment, the grip 304 includes a motor or other actuator whichcan be manipulated by a user to advance or withdraw the plunger in thehollow tube 2. The motor or actuator can operate the ratchet.

Optionally, the grip 304 is manually manipulated by a user to move theplunger 12. In one embodiment, the grip 304 includes a trigger 306. Thetrigger 306 may be hinged or pivotally interconnected to the grip 304.When the trigger 306 is actuated by a user, the plunger 12 advances inthe hollow tube 2. Specifically, in one embodiment, the trigger 306 isfunctionally interconnected to the plunger 12.

In one embodiment, actuating the trigger 306 includes pulling thetrigger toward a handle 308 of the grip. The trigger 306 can be biasedaway from the handle 308 as generally illustrated in FIG. 11. In oneembodiment, pulling the trigger 306 toward the handle 308 causes theratchet to engage the plunger 12. The ratchet engages a notch of theplunger 12 and moves the plunger toward the distal end 8 of the hollowtube. Successively pulling the trigger 306 incrementally advances theplunger 12 forward in the hollow tube.

In one embodiment, the ratchet is associated with an upper end of thetrigger 306. In this embodiment, pulling the trigger 306 causes theratchet to move toward the distal end of the hollow tube 2. Optionally,a lock pawl (not illustrated) can be associated with the grip 304. Thelock pawl can engage a notch of the plunger 12 to prevent the plungerfrom moving distally.

The grip 304 can be used to advance or withdraw the plunger 12.

Optionally, the grip 304 includes a switch operable to change thedirection of movement of the plunger 12. By manipulating the switch, auser can cause the plunger 12 to advance into the hollow tube 2 or,alternatively, withdraw from the hollow tube. In one embodiment, towithdraw the plunger 12, the plunger handle 16 can be pulled away fromthe grip 304.

Additionally, or alternatively, the grip 304 can include a knob 318. Inone embodiment, the knob 318 is configured to advance or withdraw theplunger 12 within the hollow tube 2. Specifically, rotating the knob ina first direction causes the plunger 12 to advance toward the distal end8. Rotating the knob 318 in a second direction causes the plunger 12 towithdraw away from the distal end 8.

In one embodiment, the knob 318 includes a gear, such as a pinion. Thegear includes teeth that engage notches or teeth extending linearlyalong the plunger 12, similar to a rack. Rotational movement of the knob318 is converted into linear motion of the plunger by interactionbetween the knob pinion with the plunger rack.

Optionally, the hollow tube 2 may discharge a predetermined amount ofbone graft material associated with each rotation, or partial rotationof the knob 318. Specifically, a calibrated amount of bone graftmaterial may be discharged from the hollow tube 2 for each quarter,half, or full rotation of the knob 318. In one embodiment, the hollowtube 2 is configured to discharge approximately 1 cc of bone graftmaterial for each half turn of the knob 318.

In one embodiment, the knob 318 is configured to provide tactilefeedback to a user after a predetermined amount of rotation. Forexample, when the knob is rotated one or more of ⅛, ¼, ½, and 1 turn,the knob and/or the grip 304 may vibrate or provide other tactilefeedback to the user.

The grip 304 is also operable to expand the fusion cage 60 and separatethe fusion cage 60 from the hollow tube. In one embodiment, the knob 318can slide within a slot 322 to release the fusion cage 60. In oneembodiment, pulling the knob 318 away from the distal end 8 of thehollow tube detaches the fusion cage.

A bone graft tamping device may also be provided, which is adapted to beinserted into the hollow tube 2 after the plunger 12 is removed from thehollow tube. The bone graft tamping device, according to thisembodiment, may include one or more longitudinal channels along theouter circumference of the bone graft packer for permitting any trappedair to flow from the bone graft receiving area to the graspable end ofthe hollow tube during packing of bone graft. The bone graft packer mayfurther include a handle at one end designed ergonomically for improvingease of use. The bone graft packer in this embodiment therebyfacilitates packing of bone graft within the hollow tube.

The hollow tube 2 may also be fitted with a passageway wherein asurgical tube or other device may be inserted, such as to deliver aliquid to the surgical area or to extract liquid from the surgical area.In such an embodiment, the plunger 12 is adapted in cross-section toconform to the hollow tube's cross-section.

In another embodiment of the present invention, a kit of surgicalinstruments comprises a plurality of differently sized and/or shapedhollow tubes 2 and a plurality of differently sized and/or shapedplungers 12. Each of the plungers correspond to at least one of thehollow tubes, whereby a surgeon may select a hollow tube and a plungerwhich correspond with one another depending upon the size and shape ofthe graft receiving area and the amount or type of bone graft to beimplanted at such area. The corresponding hollow tubes and plungers areconstructed and arranged such that bone graft can be placed within thehollow tubes with the plungers, and inserted nearly completely into thehollow tubes for removing substantially all of the bone graft materialfrom the hollow tubes, such as in the preferred embodiments for theplunger described above. The use of more than one hollow tube/plungercombination permits at least two different columns of material to beselectively delivered to the targeted site, e.g. one of bone graftmaterial from the patient and another of Bone Morphogenetic Protein(BMP), or e.g. two different types of bone graft material or onedelivering sealant or liquid. Also, one or both hollow tubes could bepreloaded with bone graft material.

The kit of surgical instruments may comprise a plurality of differentlysized and/or shaped graft retaining structures, each corresponding to atleast one hollow tube and at least one plunger.

The bone graft receiving area can be any area of a patient that requiresdelivery of bone graft. In the preferred embodiment, the bone graft isdelivered in a partially formed manner, and in accordance with anotheraspect of the present invention, requires further formation afterinitial delivery of the bone graft.

Another embodiment of the present invention provides a method by which ahollow tube and a plunger associated with the hollow tube are providedto facilitate delivery of the bone graft to a bone graft receiving area.

According to one embodiment, the present invention provides a bone graftdelivery system, by which a hollow tube and/or plunger assembly may beprepared prior to opening a patient, thus minimizing the overall impactof the grafting aspect of a surgical implantation or other procedure.Moreover, the hollow tube 2 may be made to be stored with bone graft init for a period of time, whether the tube is made of plastic, metal orany other material. Depending upon the surgical application, it may bedesirable to only partially fill the tube for storage, so that a plungercan be at least partially inserted at the time of a surgery.

Thus, the integrated fusion cage and graft delivery device 1 may eithercome with a pre-filled hollow tube, or a non-filled hollow tube, inwhich the surgeon will insert bone graft received from the patient(autograft), or from another source (allograft). In either case, thesurgeon may first remove any wrapping or seals about the hollow tube,and/or the pre-filled bone graft, and insert the hollow tube into thepatient such that the second end of the hollow tube is adjacent the bonegraft receiving area. Once the hollow tube is in place, and the openingat the second end of the hollow tube is oriented in the direction of thedesired placement of bone graft, the surgeon may then insert the secondend of the plunger into the opening at the first end of the hollow tube,and begin pressing the second end of the plunger against the bone graftmaterial in the hollow tube. In this fashion, the plunger 12 and hollowtube 2 cooperate similar to that of a syringe, allowing the surgeon tosteadily and controllably release or eject bone graft from the secondend of the hollow tube as the plunger is placed farther and farther intothe opening in the hollow tube. Once the desired amount of bone grafthas been ejected from the hollow tube (for in some instances all of thebone graft has been ejected from the hollow tube) the surgeon may removethe plunger from the hollow tube, and complete the surgery. In certainoperations, the surgeon may elect to place additional bone graft intothe hollow tube, and repeat the steps described above. Furthermore, thepre-filled bone graft elements may be color-coded to readily identifythe type of bone graft material contained therein.

According to the embodiment described in the preceding paragraph, thepresent invention may be carried out by a method in which access isprovided to a graft receiving area in a body, bone graft is placed intoa hollow tube having a first end and a second end, the hollow tube,together with the bone graft, is arranged so that the first end of thehollow tube is at least adjacent to the graft receiving area and permitslateral or nearly lateral (in relation to the longitudinal axis of thehollow tube and plunger assembly) introduction of bone graft to thegraft receiving area. This method prevents loss of bone graft due toimproper or limited orientation of the integrated fusion cage and graftdelivery device, and further allows a user to achieve insertion of adesired quantity of bone graft by way of the contoured plunger andhollow tube configuration described according to preferred embodimentsherein.

The method of the present invention may also be carried out by providinga hollow tube having a first end and a second end, constructed so thatit may receive a measurable quantity of bone graft, and so that thefirst end may be arranged at least adjacent to a bone graft receivingarea, and so that bone graft can be delivered from the first end of thehollow tube through the second end of the hollow tube and eventually tothe bone graft receiving area upon movement of the plunger in agenerally downward direction through the hollow tube (i.e., in adirection from the first end to the second end). According to thisembodiment, a graft retaining structure may also be provided for use inconnection with the contoured edge of the plunger, such that the graftretaining structure is positioned between the contoured edge of theplunger and the bone graft, but which is adhered to the bone graft andremains at the graft receiving area following removal from the hollowtube. In one embodiment, the bone graft is provided in discrete packagesor containers. Furthermore, this graft retaining structure may also beemployed with another tool, such as a graft packer, which is employedeither before or after the hollow tube is removed from the graftreceiving area.

In another embodiment, the one or more plungers corresponding to the oneor more hollow tubes are positioned with distal ends near the proximateend of the horizontal tube before use, said plungers having a detent toretain plunger in ready position without undesired movement beforesurgeon chooses which one or more plungers to extend through hollowhorizontal tube and deliver bone graft material and/or desired materialto the surgical area.

According to another embodiment of the present invention, a hollow tubeand plunger assembly is provided in which the hollow tube and/or theplunger assembly is disposable. Alternatively, the tube may be made of abiocompatible material which remains at least partially in the patientwithout impairing the final implantation. Thus, the hollow tube may beformed from a material that is resorbable, such as a resorbable polymer,and remain in the patient after implantation, so as not to interferewith the growth of the bone or stability of any bone graft or implant.

The current design preferably comprises a hollow tubular membercomprising a rounded edge rectangular shaft, which may be filled or ispre-filled with grafting material. The loading is carried out by theplunger. The rounded edge rectangular design is preferable as it allowsthe largest surface area device to be placed into the annulotomy site ofa disc, but in other embodiments may be formed similar to conventionalround shafts. The other preferred feature includes a laterally-mountedexit site for the graft material. The combination of this design featureallows direction-oriented dispersion of the graft material. This allowsejection of the graft material into an empty disc space as opposed tobelow the hollow tube, which would tend to impact the material and notallow its spread through a disc space.

Another feature of this design is that a rectangular, approximatelyrectangular, or rounded edge rectangular design allows the user toreadily determine the orientation of the device and thereby thedirection of entry of the bone graft material into the surgical area.However, such a feature may be obtained alternatively through exteriormarkings or grooves on the exterior on the hollow tube. Such exteriorgrooves or markings would allow use of a range of cross-sections for thedevice, to include a square, circle, or oval while allowing the user toreadily determine the orientation of the device relative to thedirection of entry of the bone graft material into the surgical area.

A further feature of this design is that an anti-perforation footing orshelf is paced on the bottom of the hollow tube to prevent annularpenetration and/or injury to the patient's abdomen or other anatomyadjacent the bone graft receiving area.

In another embodiment of the invention, all or some of the elements ofthe device or sections of all or some of the device may be disposable.Disposable medical devices are advantageous as they typically havereduced recurring and initial costs of manufacture.

In another embodiment of the device, the distal tip or end of theplunger device is composed of a different material to the rest of theplunger, so as the material at the distal end of the plunger issponge-like or softer-than or more malleable than the rest of theplunger so as upon engagement with the interior distal end of the hollowtube, the distal end of the plunger substantially conforms to theinterior configuration of the hollow tube. Similarly, the plunger distalend may be made of a material that is adaptable to substantially conformto the interior shape of the distal end of the hollow tube. Suchconfigurations enable substantially all of the material contained withinthe plunger to be delivered to the targeted site.

Another alternative embodiment to the design described herein includes anavigation aid 29 on one or more surfaces of the hollow tube 2 to permita surgeon to know how far the device 1 has been inserted or to ensureproper alignment relative to a transverse bone graft delivery site (i.e.disc space). Such capability is particularly important when the patientor surgical area is not positioned immediately below the surgeon, ormultiple procedures are being performed. A navigation aid allows moreimmediate and reliable locating of the surgical area for receiving ofbone graft material. In one embodiment, the hollow tube 2 is scored ormarked 29 or provides some affirmative indication, actively orpassively, to the surgeon to indicate degree of delivery of thematerial, e.g. bone graft material, to the delivery site, and/orposition of the plunger 12. For example, the exterior of the hollow tubecould be color-coded and/or provided with bars 29. In anotherembodiment, a computer and/or electro-mechanical sensor or device isused to provide feedback to the surgeon to indicate degree of deliveryof the material, e.g. amount of cc's of bone graft material, to thedelivery site, and/or position of the plunger element.

In another alternative embodiment to the design described herein, theplunger 12 could include an activation device, which is often in aliquid or semi-liquid state, and that may be injected once thesemi-solid portion of the morphogenic protein has been displaced by themovement of the plunger through the hollow tube 2. That is, the plunger12 pushes the dry material, and once completed has a bulb or otherdevice on the usable end to insert the liquid portion of the activatingagent through the inner lumen 28 within the plunger 12 to evacuate theliquid from the plunger and out an opening at the non-usable end of theplunger so as to contact the dry material already inserted into the discspace).

In one embodiment of the device, all or portions of the device 1 aremanufactured using 3-D printing techniques. In another embodiment, allor portions of the device are made by injection molding techniques.

In one embodiment, the ratio of the surface area of the bottom tip ofthe plunger 12 is approximately half the surface area of the two lateralopenings at the distal portion of the hollow tube.

In one embodiment, the device 1 includes a supplemental means ofgripping the device, such as a laterally extending cylindrically-shapedhandle that engages the hollow tube 2.

In one embodiment, the material inserted into the hollow tube 2 is anon-Newtonian fluid. In one embodiment, the device is adapted to acceptand deliver compressible fluids. In another embodiment, the device isadapted to accept and deliver non-compressible fluids. The hollow tube 2of one embodiment includes a rectangular or approximately rectangularlumen 28 which provides an increased cross-sectional footprint relativeto a round lumen of other bone graft delivery devices. The increasedcross-sectional footprint decreases friction of the non-Newtonian fluidmaterial against the interior walls of the lumen, resulting in animproved flow of bone graft material through the lumen and eliminating(or reducing) jamming due compression of the bone graft material. Theincreased cross-section of hollow tube 2 of the present disclosureimproves the flow dynamics of a non-Newtonian fluid by 40% compared to aprior art tool with a diameter equal to the height of the rectangular orapproximately rectangular lumen of embodiments of the present invention.

In one embodiment, the upper portion of plunger is fitted with one ormore protrusions, which extends from the surface of the plunger so as toengage the upper surface of the hollow tube, to prevent the plunger fromengaging the distal interior portion of the hollow tube. In oneembodiment, the upper portion of plunger is fitted with one or moreprotrusions to prevent the plunger from engaging the apex of the hollowtube distal interior ramp surface.

In one embodiment, the funnel 30 attaches to the hollow tube 2 by abayonet connection. In one embodiment, the funnel attaches to the hollowtube by an interference fit. In one embodiment, the funnel attaches tothe hollow tube by a threaded connection. In one embodiment, the funnelattaches to the hollow tube by a slot/groove connection.

In one embodiment, the distal end 8 of hollow tube has one opening 7. Inone embodiment, the hollow tube 8 has two distal openings 7A, 7B locatedon opposite sides. In one embodiment, the hollow tube has no more thantwo openings 7, the openings located on opposite sides.

In one embodiment, after bone graft material 44 is delivered to asurgical site 172, a cavity 174 approximately defined by the volumeengaged by the device 1 when inserted into the surgical site is left inthe surgical site upon removal of the device from the surgical site. Inone embodiment, the cavity 174 is then used as the site for insertion ofa fusion cage 60.

The integrated fusion cage 60 with expandable cage feature provides anumber of unique and innovative features not provided by conventional ortraditional integrated fusion cages. For example, the integrated fusioncage with expandable cage feature of the disclosure is intentionally anddeliberately designed to receive bone graft material (or any materialsuitable for use in surgical applications, as known to those skilled inthe art) at its proximal end (i.e. the end generally facing the surgeonand/or the end opposite the end initially directed into a surgicalsite), such that the bone graft material flows into the fusion cage andalso flows out from the fusion cage into the surgical site. Suchfeatures as the interior ramps of the fusion cage (e.g. located withinthe interior of the hollow tube, and/or on the front and/or rear blocksof the fusion cage) function to direct received bone graft material intothe surgical site. Additionally, the features of the hollow tube andplunger wherein a greater volume of bone graft material may be reliably(e.g. not prone to blockage as is typical with most convention e.g.round hollow tubes or lumen systems) and readily delivered to a surgicalsite and/or a fusion cage are unique and not found in the prior art.Among other things, such features encourage improved surgical results bydelivering more volume and coverage of bone graft material to thesurgical site. Also, such features minimize gaps in bone graft coverageto include gaps between the fusion cage area and the surroundingsurgical site. Also, the features of the one or more apertures of thefusion cage of the disclosure enable and encourage delivery of bonegraft material, as received by the fusion cage, into the surroundingsurgical site.

In contrast, conventional fusion cages, to include expandable fusioncages, do not provide such features and/or functions. For example, U.S.Pat. No. 8,852,242 to Morgenstern Lopez (“Lopez”), discloses a dilationintroducer for orthopedic surgery for insertion of an intervertebralexpandable fusion cage implant. The Lopez device does not allow receiptof bone graft material from its proximal end, or any end, in contrast tothe disclosed fusion cage and fusion cage/bone graft delivery system.That is, the Lopez proximal end includes an array of components, all ofwhich do not allow receipt of bone graft material. Furthermore, theLopez device requires an elaborate array of components, e.g. upper sideportion of the upper body portion and lower side portion of the lowerbody portion, which also block any egress of bone graft from the insideof the Lopez fusion cage once deployed. Also, the Lopez wedges occupythe entire interior of the cage; there are no ramps to direct graft fromthe interior to the disk space. In short, the Lopez design is not madewith bone graft delivery in mind, and indeed, cannot function to acceptlet alone deliver bone graft. Additionally, suggestions provided in theLopez disclosure to deliver bone graft to the surgical site would notprovide the integrated and complete fusion cage and surgical site bonegraft delivery of the invention, e.g. the Lopez slot of the Lopez lumenand funnel assembly at best provides limited delivery of bone graftmaterial only before and after insertion of the Lopez fusion cage, andthen only peripheral to the fusion cage. Also, it appears the Lopezdevice provides wedges and of similar if not identical interior rampangles. In contrast, in certain embodiments of the present invention theinterior wedged surfaces of the invention, i.e. front block ramp 226 andrear block ramp 236, are not of the same configuration and/or shape,e.g. front block ramp 226 is of a curved profile and rear block ramp 236is of a linear or straight-line profile. Among other things, the curvedprofile of the front block ramp 226 urges egress of bone graft asreceived by the fusion cage 60.

In one embodiment of the fusion cage 60, no anti-torque structures orcomponents are employed. In one embodiment of the invention, the lateralsides of the fusion cage 60 are substantially open to, among otherthings, allow egress of bone graft material as received to the fusioncage. In one embodiment, the expansion screw 240 is configured with alocking mechanism, such that the fusion cage 60 may be locked at a setexpansion state. In one embodiment, such a locking mechanism is providedthrough a toggle device operated at or on the installer/impactor handle258.

In one embodiment, the front block ramp 226 and rear block ramp 236 areidentical and/or symmetrical.

In addition, it is contemplated that some embodiments of the fusion cage60 can be configured to include side portions that project therefrom andfacilitate the alignment, interconnection, and stability of thecomponents of the fusion cage 60.

Furthermore, complementary structures can also include motion limitingportions that prevent expansion of the fusion cage beyond a certainheight. This feature can also tend to ensure that the fusion cage isstable and does not disassemble during use.

In some embodiments, the expansion screw 240 can facilitate expansion ofthe fusion cage 60 through rotation, longitudinal contract of a pin, orother mechanisms. The expansion screw 240 can also facilitate expansionthrough longitudinal contraction of an actuator shaft as proximal anddistal collars disposed on inner and outer sleeves move closer to eachother to in turn move the proximal and distal wedged block memberscloser together. It is contemplated that in other embodiments, at leasta portion of the actuator shaft can be axially fixed relative to one ofthe proximal and distal wedge block members with the actuator shaftbeing operative to move the other one of the proximal and distal wedgemembers via rotational movement or longitudinal contraction of the pin.

Further, in embodiments wherein the engagement screw 240 is threaded, itis contemplated that the actuator shaft can be configured to bring theproximal and distal wedged block members closer together at differentrates. In such embodiments, the fusion cage 60 could be expanded to aV-configuration or wedged shape. For example, the actuator shaft cancomprise a variable pitch thread that causes longitudinal advancement ofthe distal and proximal wedged block members at different rates. Theadvancement of one of the wedge members at a faster rate than the othercould cause one end of the implant to expand more rapidly and thereforehave a different height that the other end. Such a configuration can beadvantageous depending on the intervertebral geometry and circumstantialneeds.

In other embodiments, an upper plate 200 can be configured to includeanti-torque structures. The anti-torque structures can interact with atleast a portion of a deployment tool during deployment of the fusioncage 60 implant to ensure that the implant maintains its desiredorientation. For example, when the implant is being deployed and arotational force is exerted on the actuator shaft, the anti-torquestructures can be engaged by a non-rotating structure of the deploymenttool to maintain the rotational orientation of the implant while theactuator shaft is rotated. The anti-torque structures can comprise oneor more inwardly extending holes or indentations on the rear wedgedblock member. However, the anti-torque structures can also comprise oneor more outwardly extending structures.

According to yet other embodiments, the fusion cage 60 can be configuredto include one or more additional apertures to facilitateosseointegration of the fusion cage 60 within the intervertebral space.The fusion cage 60 may contain one or more bioactive substances, such asantibiotics, chemotherapeutic substances, angiogenic growth factors,substances for accelerating the healing of the wound, growth hormones,antithrombogenic agents, bone growth accelerators or agents, and thelike. Indeed, various biologics can be used with the fusion cage 60 andcan be inserted into the disc space or inserted along with the fusioncage 60 The apertures can facilitate circulation and bone growththroughout the intervertebral space and through the implant. In suchimplementations, the apertures can thereby allow bone growth through theimplant and integration of the implant with the surrounding materials.

In one embodiment, the fusion cage 60 comprises an expandable cageconfigured to move a first surface vertically from a second surface byrotation of at least one screw that rotates without moving transverselywith respect to either said first or second surface, said first plateand second plate having perimeters that overlap with each other in avertical direction and that move along a parallel line upon rotation ofthe screw.

In one embodiment, the fusion cage 60 is stackable by any means known tothose skilled in the art. For example, each upper plate 200 may befitted with one or more notches on the lateral edges configured to fitwith one or more protrusions on each lower plate 210.

Surprisingly, while conventional practice assumed that the amount ofmaterial that would be required, let alone desired, to fill a prepareddisc space with bone paste (or BMP, etc.) would be roughly equivalent tothe amount of material removed from such space prior to inserting acage, a present inventor discovered that far more bone graft materialcan be—and should preferably be—inserted into such space to achievedesired fusion results. The reasons why this basic under appreciationfor the volume of bone graft necessary to achieve optimal fusion resultsvary, but the clinical evidence arrived at via practice of the presentinvention compellingly demonstrates that more than doubling of theamount of bone graft material (and in some cases increasing the amountby 200%, 300% or 400% or more) than traditionally thought necessary orsufficient, is extremely beneficial to achieving desired results fromfusion procedures.

The ramifications of this simple yet dramatic discovery (documented inpart below) is part of the overall inventive aspect of the presentinvention, as it has been—to date—simply missed entirely by thepracticing spine surgeons in the field. The prospect of reduced returnsurgeries, the reduction in costs, time, and physical suffering bypatients, as well as the volume of legal complaints against surgeons andhospitals due to failed fusion results, is believed to be significant,as the evidence provided via use of the present invention indicates avast reduction in the overall costs involved in both economic resources,as well as emotional capital, upon acceptance and wide-spread use of thepresent invention. Insurance costs should thus decrease as the presentinvention is adopted by the industry. While the costs of infusingincreased amount of bone graft materials into the space of a patient'sdisc may at first appear to increase the costs of an individualoperation, the benefits achieved thereby will be considerable, includingthe reduction of repeat surgeries to fix non-fused spines. Thus,regardless of the actual tools and devices employed to achieve the endresult of attaining up to 100% more bone graft material being utilizedin fusion operations, (as well as other surgeries where previouslyunder-appreciated bone graft material delivery volumes have occurred)one important aspect of the present invention is directed to theappreciation of a previously unrecognized problem and the solutionthereto, which forms part of the inventive aspects of the presentinvention described and claimed herein.

In one embodiment, at least twice the amount of disc material removedfrom a surgical site is replaced with bone graft material. In apreferred embodiment, at least three times the amount of disc materialremoved from a surgical site is replaced with bone graft material. In amost preferred embodiment, at least three and a half times the amount ofdisc material removed from a surgical site is replaced with bone graftmaterial.

According to various embodiments of the present disclosure, and asillustrated at least by FIGS. 1 and 6-10D, one aspect of the inventionis to provide a graft delivery device that comprises a tubular member,which is substantially hollow or contains at least one inner lumen andthat has a generally rectangular cross-sectional shape. This generallyrectangular cross-sectional shape offers a larger amount of surface areathrough which bone graft material may be inserted and ejected from thehollow tubular member. Furthermore, this generally rectangular shape ismore congruent with the size or shape of the annulotomy of most discspaces, which frequently are accessed by a bone graft delivery devicefor delivery of bone graft. However, as one skilled in the art wouldappreciate, the tool cross-section need not be limited to a generallyrectangular shape. For example, cross-sections of an oval shape, orthose that are approximately rectangular and have rounded corners oredges, or those with at least one defined angle to include obtuse,acute, and right angles can provide a shape in some situations that ismore congruent with the size or shape of the annulotomy of a particulardisc space. A substantially round shape may also be employed thatprovides the surgeon with an indication of directional orientation.

In embodiments, a distal end of the hollow tubular member may be atleast partially closed, and/or may have a small aperture associated withthe lumen. This partial closure and/or small aperture may help to createa consistent and clean break between bone graft material that has beenejected from the hollow tubular member and bone graft material heldwithin the hollow tubular member.

In another embodiment of the present disclosure the distal end of theplunger is flexible to allow, for example, the user to maneuver thedistal end and thereby any bone graft material in the hollow tube to theimplantation site. One skilled in the art will appreciate that theflexible aspect of certain embodiments can be both passive and active innature. Active flexibility and manipulation in the distal end of theplunger may incorporate, for example, the manipulative capabilities ofan endoscope, including components for manipulation such as guidewiresalong the longitudinal axis of the shaft of the plunger.

The plunger 12 may be inserted into the hollow tube 2 such that thehorizontal face 19 is substantially planar with the opening at thesecond end 8 of the hollow tube 2. As described above, the geometry ofplunger 12 is such that it fits snugly or tightly in the interior of thehollow tube 2. This configuration is such that the sloped or curvedsurface 10 of the hollow tube 2 is substantially congruent to the slopedor curved surface 20, thereby allowing the plunger to be inserted intothe hollow tube 2 and allowing substantially all of bone graft materialwhich is placed into the hollow tube 2 to be ejected by the user.

Another embodiment for the bone graft insertion device comprises ahollow tube constructed to receive bone graft, where the hollow tube hasa proximal and distal end, a plunger adapted for insertion at leastpartially within the hollow tube at the proximal end of the hollow tube,whereby the plunger is constructed and arranged with respect to thehollow tube so as to prevent rotation of the plunger during insertioninto said hollow tube, whereby the plunger has a distal end that iscontoured to an interior surface of the distal end of the hollow tubefor removing substantially all of the bone graft received by the hollowtube and whereby the bone graft is delivered to the graft receivingarea. Still another embodiment provides a rifling structure in thehollow tube interior that facilitates rotational movement of the plungeralong a lengthwise axis of the hollow tube, therein delivering asubstantially steady pressure and/or rate of delivery of the bone graftmaterial as the plunger descends the hollow tube when the plunger isforced through the hollow tube. The rifling or screw-like movement mayalso translate to a predetermined delivery of material per fullrotation, e.g. each 360 degree rotation of the plunger equates to 5 ccof bone graft material delivered to the bone graft site.

In embodiments, teeth may be formed along a longitudinal axis of theshaft of the plunger 12, which may be configured to engage with teeth ofthe grip 304 and/or knob 318 to facilitate advancement of the plunger 12when the grip 304 and/or knob 318 is actuated. The engagement of theteeth of the plunger 12 with teeth of the grip 304 and/or knob 318 maythus, by way of non-limiting example, form a rack-and-pinion-type linearactuator that causes the plunger 12 to descend the hollow tube 2 andurge bone graft material through the hollow tube 2 to deliver bone graftmaterial through an opening in a distal end of the hollow tube 2.

The indicia 29 may include one or more radiological or radiographicmarkers. Such radiological or radiographic markers may be made fromknown radiopaque materials, including platinum, gold, calcium, tantalum,and/or other heavy metals. At least one radiological or radiographicmarker may be placed at or near the distal end of the hollow tube 2, toallow radiological visualization of the distal end within the targetedbone area.

In further embodiments, an actuating means may be provided for applyingpressure to the plunger 12, and in particular to the shaft of theplunger 12. Upon actuation thereof, the actuating means may applypressure against the plunger 12 to facilitate controlled movement of theplunger 12 and/or the hollow tube 2 relative to the plunger 12. Theactuating means may, by way of non-limiting example, include a handleand a pivotally mounted trigger attached to a ratchet-type push bar(such as those commonly used with caulking guns) and/or arack-and-pinion-type linear actuator.

According to a still further aspect of the present invention, the distalend of the spinal fusion implant may have a conical (bullet-shaped)shape including a pair of first tapered (angled) surfaces and a pair ofsecond tapered (angled) surfaces. The first tapered surfaces extendbetween the lateral surfaces and the distal end of the implant, andfunction to distract the vertebrae adjacent to the target intervertebralspace during insertion of the spinal fusion implant. The second taperedsurfaces extend between the top and bottom surfaces and the distal endof the spinal fusion implant, and function to maximize contact with theanterior portion of the cortical ring of each adjacent vertebral body.Furthermore, the second tapered surfaces provide for a better fit withthe contour of the vertebral body endplates, allowing for a moreanterior positioning of the spinal fusion implant and thus advantageousutilization of the cortical rings of the vertebral bodies.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise a covering or mesh, such as abiodegradable polymer mesh, and/or may be detachably interconnected tothe bone graft insertion device by means of, e.g., a hook attachmentmechanism, a screw attachment mechanism, a mechanical attachmentmechanism, a suture attachment mechanism, a wrap attachment mechanism,and/or an adhesive attachment mechanism. Examples of spinal implants ofthis type, suitable for use in the present invention, include but arenot limited to the spinal implants described in U.S. Pat. No.10,028,837, issued Jul. 24, 2018 to Wei et al., the entirety of which isincorporated herein by reference.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise an expandable portion adapted to expand orinflate when filled with bone graft or other material, and/or may bedetachably interconnected to the bone graft insertion device by meansof, e.g., an adhesive. Examples of spinal implants of this type,suitable for use in the present invention, include but are not limitedto the spinal implants described in U.S. Pat. No. 9,925,060, issued Mar.27, 2018 to DiMauro et al., the entirety of which is incorporated hereinby reference.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise any one or more of a nucleus replacementdevice, a nucleus augmentation device, an anulus augmentation device, ananulus replacement device, a drug carrier device, a carrier deviceseeded with living cells, a device that stimulates or supports fusion ofthe surrounding vertebra, and/or a membrane that prevents flow of amaterial through a defect in a disc of the patient; the implant may bewholly or partially rigid or wholly or partially flexible. Examples ofspinal implants of this type, suitable for use in the present invention,include but are not limited to the spinal implants described in U.S.Pat. No. 9,333,087, issued May 10, 2016 to Lambrecht, the entirety ofwhich is incorporated herein by reference.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise any one or more of a plate, spacer, rod,or other stabilization device, and in particular may comprise anexpandable or non-expandable spacer having an opening for receivinggraft material therein, and/or may (but need not) be detachablyinterconnected to the bone graft insertion device by means of, e.g., athreaded attachment. Examples of spinal implants of this type, suitablefor use in the present invention, include but are not limited to thespinal implants described in U.S. Pat. No. 9,827,113, issued Nov. 28,2017 to Klimek et al., the entirety of which is incorporated herein byreference.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise a body portion, a carriage portion, adeployment assembly, and an expandable portion, and/or may be detachablyinterconnected to the bone graft insertion device by means of, e.g., oneor more detents and holes or apertures for receiving the detents.Examples of spinal implants of this type, suitable for use in thepresent invention, include but are not limited to the spinal implantsdescribed in U.S. Pat. No. 10,076,421, issued Sep. 18, 2018 to Dewey,the entirety of which is incorporated herein by reference.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise a gear and a threaded shaft, wherebyrotation of the gear engages the threaded shaft to expand the implantsuch that the implant can be inserted in a collapsed configuration andexpanded in situ, and/or may (but need not) be detachably interconnectedto the bone graft insertion device by means of, e.g., screws, clips,hooks, and/or clamps. Examples of spinal implants of this type, suitablefor use in the present invention, include but are not limited to thespinal implants described in U.S. Pat. No. 10,226,358, issued Mar. 12,2019 to Glerum, the entirety of which is incorporated herein byreference.

In embodiments of bone graft insertion devices and systems of thepresent invention, a spinal implant adapted for interconnection and usewith the bone graft insertion device and/or included in the bone graftinsertion system may comprise a plurality of chambers, each of thechambers being configured to receive bone graft material, and/or mayinclude means allowing a surgeon or other user to select a chamber orportion of the interior of the implant into which bone graft material isdelivered. Examples of spinal implants of this type, suitable for use inthe present invention, include but are not limited to the spinalimplants described in U.S. Pat. No. 9,545,282, issued Jan. 17, 2017 toMathur et al., the entirety of which is incorporated herein byreference.

It is to be expressly understood that spinal implant suitable for use aspart of, or in conjunction with, the devices, methods, and systems ofthe present invention are not limited to the examples described above,and that any type of spinal implant appropriate for a given applicationmay be detachably interconnected to a bone graft delivery device andused in the methods and systems of the present invention. By way ofnon-limiting example, anterior and/or lateral interbody spinal implants,including but not limited to implants available under the SeaSpineRedondo™, Regatta®, and Vu a•POD™ product lines, may be detachablyinterconnected to a bone graft delivery device by any suitable means andused in the practice of the present invention. By way of furthernon-limiting example, posterior interbody spinal implants, including butnot limited to implants available under the SeaSpine Hollywood™,Hollywood™ VI, Pacifica™ Steerable Interbody, Ventura®, and Vu a•POD™product lines, may be detachably interconnected to a bone graft deliverydevice by any suitable means and used in the practice of the presentinvention. These and other spinal implants suitable for use in thepresent invention are described in U.S. Pat. Nos. 7,799,083, 7,976,549,7,988,695, 8,100,972, 8,142,508, 8,292,958, 8,366,774, 8,409,290,8,506,636, 8,545,562, 8,673,012, 8,864,829, and 9,522,069, the entiretyof each of which is incorporated herein by reference.

While various embodiment of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A method for delivering graft material into asurgical site, comprising: (a) providing a hollow tube configured toreceive the graft material, the hollow tube having a longitudinal axis,a proximal end, a distal end with at least one opening, and a lumenextending from the proximal end to the distal end; (b) releasablyattaching an implant to the distal end of the hollow tube so as tocommunicate with the at least one opening in the distal end of thehollow tube, the implant being configured to receive the graft materialdelivered through the hollow tube; (c) placing the implant within thesurgical site; (d) advancing the graft material through the lumen of thehollow tube; (e) conveying graft material through the at least oneopening of the distal end of the hollow tube into an interior of theimplant, whereby the implant is at least substantially filled with thegraft material; and (f) discharging the graft material through at leastone opening in the implant into the surgical site, whereby the surgicalsite is at least substantially filled with the graft material.
 2. Themethod of claim 1, further comprising the step of releasing the distalend of the hollow tube from the implant.
 3. The method of claim 1,further comprising the step of providing a plunger adapted to travel inthe lumen of the hollow tube, the plunger having a shaft and a distalportion configured to advance graft material along the longitudinal axisof the hollow tube.
 4. The method of claim 3, wherein the step ofadvancing the graft material through the lumen of the hollow tube isperformed using the plunger.
 5. The method of claim 4, furthercomprising the step of introducing the graft material into the proximalend of the hollow tube using a funnel detachably connected to theproximal end.
 6. The method of claim 1, wherein the implant is anexpandable fusion cage, and wherein the method further comprises thestep of expanding the fusion cage.
 7. The method of claim 6, wherein theexpanding step includes rotating an expansion screw of the fusion cageto vertically move a first plate of the fusion cage away from a secondplate of the fusion cage.
 8. The method of claim 1, wherein the surgicalspace is an intervertebral disc space, and the method further includesthe step of debriding the disc space.
 9. The method of claim 1, whereinthe graft material includes bone graft material.
 10. A method fordelivering graft material into a surgical site, comprising: (a)providing a hollow tube configured to receive the graft material, thehollow tube having a longitudinal axis, a proximal end, a distal endwith at least one opening, and a lumen extending from the proximal endto the distal end; (b) releasably attaching an implant to the distal endof the hollow tube so as to communicate with the at least one opening inthe distal end of the hollow tube, the implant being configured toreceive the graft material delivered through the hollow tube; (c)placing the implant within the surgical site; (d) providing a plungeradapted to travel in the lumen of the hollow tube, the plunger having ashaft and a distal portion configured to advance graft material alongthe longitudinal axis of the hollow tube; (e) advancing the graftmaterial through the lumen of the hollow tube using the plunger; (f)conveying the graft material through the at least one opening of thedistal end of the hollow tube into an interior of the implant; (g)discharging the graft material through at least one opening in theimplant into the surgical site; and (h) releasing the distal end of thehollow tube from the implant.
 11. The method of claim 10, wherein theimplant includes at least one interior ramp configured to discharge thegraft material from the at least one opening into the surgical site. 12.The method of claim 10, wherein the implant is an expandable fusioncage, and wherein the method further comprises the step of expanding theimplant.
 13. The method of claim 12, wherein the expanding step includesrotating an expansion screw of the fusion cage to vertically move afirst plate of the fusion cage away from a second plate of the fusioncage.
 14. The method of claim 10, wherein the surgical space is anintervertebral disc space, and the method further includes the step ofdebriding the disc space.
 15. The method of claim 10, wherein theimplant is an intervertebral implant, and includes a first texturedsurface and a second textured surface, and wherein the implant placingstep includes engaging a first vertebrae with the first texturedsurface, and engaging a second vertebrae with the second texturedsurface.
 16. The method of claim 10, wherein the graft material includesbone graft material.
 17. A method for delivering graft material into asurgical site, comprising: (a) providing a hollow tube configured toreceive the graft material, the hollow tube having a longitudinal axis,a proximal end, a distal end with at least one opening, and a lumenextending from the proximal end to the distal end; (b) releasablyattaching a fusion cage to the distal end of the hollow tube so as tocommunicate with the at least one opening in the distal end of thehollow tube, the fusion cage being configured to receive the graftmaterial delivered through the hollow tube, and the fusion cage beingconfigured to be expandable; (c) placing the fusion cage within thesurgical site; (d) expanding the fusion cage from an unexpanded state toan expanded state; (e) advancing the graft material through the lumen ofthe hollow tube; (f) conveying the graft material through the at leastone opening of the distal end of the hollow tube into an interior of thefusion cage; (g) discharging the graft material through at least oneopening in the fusion cage into the surgical site; and (h) releasing thedistal end of the hollow tube from the fusion cage.
 18. The method ofclaim 17, wherein the fusion cage includes a center, a first plate, asecond plate, a front block, a rear block and a screw operably connectedto the first plate, second plate, front block and rear block; andwherein the expanding step includes rotating the screw to advance thefront block and rear block toward the center of the fusion cage andsimultaneously advance the first plate and second plate away from thecenter of the fusion cage, thereby increasing an overall height of thefusion cage.
 19. The method of claim 18, wherein the at least oneopening in the fusion cage includes a first opening formed in the firstplate and a second opening formed in the second plate.
 20. The method ofclaim 17, further comprising the step of introducing the graft materialinto the proximal end of the hollow tube using a funnel detachablyconnected to the proximal end.